the current main types of capsule endoscopy

2The Current Main Types of CapsuleEndoscopy

Zhaoshen Li, Dan Carter, Rami Eliakim,Wenbin Zou, Hao Wu, Zhuan Liao, Zhaotao Gong,Jinshan Wang, Joo Won Chung, Si Young Song,Guohua Xiao, Xiaodong Duan and Xinhong Wang

2.1 The Given Imaging CapsuleEndoscopy Platform: ClinicalUse in the Investigationof Small Bowel, Esophagealand Colonic Diseases

2.1.1 Introduction

The first video capsule endoscope was introducedin 2001 by Iddan as a new tool for the investiga-tion of the small bowel [1]. Initially called mouthto anus (M2A), its goal was small bowel visuali-zation. Since then, various studies have shown thepotential of this minimally invasive technique toimprove diagnostic outcomes among a variety ofgastrointestinal (GI) conditions. Later on, theesophageal and colonic capsules [2, 3] werelaunched into the market, and the patency capsulewas introduced as well. The introduction of thesecond or even third generation of capsulesenabled broadening the horizon for its possiblemedical use (Fig. 2.1, Table 2.1). To date, mul-tiple capsule endoscopy (CE) systems are avail-able (Fig. 2.2), mostly for the small bowel. Asmentioned, the first capsule endoscopy systemwas manufactured by Given Imaging (Yokneam,Israel). To date, the Given Imaging platform ofcapsule endoscopes includes the PillCam SB2 andSB3 for the small intestine, the PillCam ESO2 foresophageal imaging, PillCam Colon2 for the large

Z. Li (&) � W. Zou (&) � H. Wu � Z. Liao (&) �G. Xiao X. Duan � X. WangDepartment of Gastroenterology, ChanghaiHospital, Second Military Medical University, 168Changhai Road, Yangpu District, Shanghai, 200433Chinae-mail: [email protected]

W. Zoue-mail: [email protected]

Z. Liaoe-mail: [email protected]

D. CarterDepartment of Gastroenterology, Chaim ShebaMedical Center, 2nd Sheba Road, 52621Ramat-Gan, Israele-mail: [email protected]

Z. T. Gong � J. S. WangChongqing Jinshan Science and Technology Co.,Ltd., Chongqing, China

J. W. ChungDivision of Gastroenterology, Department ofInternal Medicine, National Medical Center, 245Euljiro, Jung-gu, Seoul, 100-799 Koreae-mail: [email protected]

S. Y. Song (&)Division of Gastroenterology, Department ofInternal Medicine, Yonsei University College ofMedicine, Brain Korea 21 Project for MedicalScience, 250 Seongsanno, Seodaemun-gu, Seoul,Koreae-mail: [email protected]

R. Eliakim (&)Head Department of Gastroenterology, ChaimSheba Medical Center, 2nd Sheba Road, 52621Ramat-Gan, Israele-mail: [email protected]

Z. Li et al. (eds.), Handbook of Capsule Endoscopy,DOI: 10.1007/978-94-017-9229-5_2, � Springer Science+Business Media Dordrecht 2014

5

bowel, as well as the Agile Patency capsule(second generation) (Fig. 2.3). Additional smallbowel capsule systems include the Olympus En-doCapsule (Olympus, Japan) [4], the ChineseOMOM pill (Jinshan science and technology,Chongqing, China) [5], the Korean Miro pill [6],

and the American CapsoCam SV-1. Comparativestudies between the PillCam SB1 and the Olym-pus EndoCapsule or the Korean Miro Capsule didnot show significant differences. Currently, onlythe Given PillCam SB system and the OlympusEndoCapsule are FDA- and CE-approved.

Fig. 2.1 PillCam smallbowel 3 capsule endoscopesystem

6 Z. Li et al.

The PillCam SB3 video capsule endoscopysystem consists of (a) a 2 9 11 mm capsulecontaining the video camera, illumination, andbatteries; (b) a sensing system comprising anarray of sensor pads, a data recorder, and abattery pack; and (c) a workstation, based on acommercially available personal computer(Fig. 2.1). The new data recorders (DR3) alsocontain a portable real-time viewer that allowsdirect monitoring of the images received during

Table 2.1 Indications for the use of capsule endoscopyaccording to anatomic site

Esophagus

Gastroesophageal reflux disease

Barrett’s esophagus

Esophageal varices

Small Bowel

Obscure gastrointestinal bleeding

Suspected Crohn’s disease

Suspected small bowel tumor

Evaluation of any abnormal small bowel imaging

Evaluation of partially responsive celiac disease

Surveillance of inherited polyposis syndromes

Evaluation of drug-induced small bowel injury

Evaluation of mucosal response to medications

Colon

Polyp screening

Fig. 2.2 Various systems of capsule endoscopes available for the small bowel

Fig. 2.3 The Agile patency capsule system

2 The Current Main Types of Capsule Endoscopy 7

the examination. While the PillCam capturesimages using a complementary metal-oxidesemiconductor (CMOS) sensor, the EndoCap-sule, MiroCam, and OMOM capsule use acharge-coupled device camera (CCD). The fourcapsules also differ with regard to dimensions,image acquisition frame rate, field of view, andrecording duration.Almost all of the information provided in theliterature is regarding the Given Imaging Pill-Cam SB, as it dominated the market for a fewyears by itself, later on joined by the other smallbowel capsules, and thus is the one on whichmost of the literature is written.

2.1.2 Small Bowel Video CapsuleEndoscopy

Until the introduction of the small bowel videocapsule endoscopy (SBCE), the small bowel wasan organ that was very difficult to explore with theavailable techniques. Since its development,SBCE provided a reliable, noninvasive, and well-accepted and well-tolerated procedure, which hasrevolutionized the study of the small bowel.

PillCam SB3 video capsule endoscope is awireless capsule (11 9 26 mm) comprised of alight source, lens, CMOS imager, battery, and awireless transmitter. A slippery coating allowseasy ingestion and prevents adhesion of bowelcontents, as it moves via peristalsis from themouth to the anus (Figs. 2.1, 2.4). The batteryprovides [11 h of work in which the capsulephotographs using an adaptive frame rate tech-nique two to six images per second ([80,000images all together), in a 156� field of view and8:1 magnification. The pictures are transmittedvia a newly developed ‘no attachments’ sensorbelt, to a small data recorder (DR3) which alsoallows real-time imaging. The recorder isdownloaded into a Reporting and Processing ofImages and Data computer workstation (RAPID8) and seen as a continuous video film. Supportsystems have been added since the first prototypeof the RAPID system, including a localizationsystem, a blood detector, a double and quadric

picture viewer, a ‘quick viewer,’ single pictureadjustment mode, incorporation of the FujiIntelligent Color Enhancement (FICE) system,an inflammation (Lewis) scoring system, and anatlas, all meant to assist the interpreter.

The procedure: The patient is on clear liq-uids the day prior to the procedure and swallowsthe capsule with water after a 12-h fast. Drinkingclear fluids is allowed 2 h after ingestion as is alight lunch after 4 h. During the procedure, he isfree to do his daily activities.

Fig. 2.4 Small bowel pictures taken with PillCam SB3:a Ampulla of Vater. b Small bowel normal mucosa

8 Z. Li et al.

A few grading scales have been developed toassess the quality of bowel preparation in videocapsule endoscopy, the most recent being acomputer-assisted cleansing score (CAC) [7].The impact of bowel preparation on the imagequality and transit time was assessed in twometa-analyses. Preparation was found toimprove the quality of visualization, but had noeffect on transit times or percentage of capsulesreaching the cecum, and no consensus wasreached as to the effects on the diagnostic yieldof the study [8, 9]. Another attempt to improvethe small bowel diagnostic yield was attemptedby using a capsule with two cameras (one oneach side), which resulted in diagnosis of morelesions [10].

The main indications for SBCE include thefollowing:1. Obscure gastrointestinal bleeding2. Crohn’s disease (suspected/known)3. Suspected small bowel tumor4. Evaluation of abnormal small bowel imaging5. Partially/non-responsive celiac disease6. Surveillance of inherited polyposis syndromes7. Evaluation of drug-induced small bowel

injury and response to medications

Contraindications include the following:1. History of or suspected small bowel

obstruction2. Swallowing disorders3. Pregnancy4. Non-compliance

Relative contraindications are as follows:1. Major abdominal surgery in the previous

6 months.2. Cardiac devices—pacemaker/defibrillator.

Although the capsule is easily ingested andswallowed by most individuals, patients withsevere dysphagia, large Zenker’s diverticulum,pill phobia, significant gastroparesis, and smallchildren may have problems ingesting thedevice. For these situations, a capsule-loadingdevice (AdvanCE, US Endoscopy, Mentor,Ohio, USA) is available to directly deliver thecapsule into the stomach or duodenum.

In case of suspected small bowel obstruction,the use of a patency capsule (the AGILE cap-sule, Given Imaging, Yokneam, Israel) has beenshown to provide evidence of the functionalpatency of the gastrointestinal tract [10](Fig. 2.3). This system consists of a self-disin-tegrating capsule without a camera that containsradio frequency identification (RFID) tag and aRFID scanner. In a case of obstructive smallbowel pathology, the AGILE capsule disinte-grates within 30 h, and the remnants can passthrough even small orifices [11]. The radio-opaque capsule can be detected by plainabdominal X-ray.

2.1.3 Occult GI Bleeding

Occult GI bleeding accounts for up to two-thirdsof SBCE studies performed [12]. It was shownthat 20–38 % of patients with normal upper andlower endoscopy have significant intestinallesions [13, 14] (Fig. 2.5). SBCE has beenshown to be superior to push enteroscopy,abdominal computed tomography, abdominalmagnetic resonance and angiographic studies[15–18], and as good as balloon-assisted smallbowel enteroscopy [19], with diagnostic yieldbetween 39 and 90 % [20]. Moreover, the rate ofrebleeding in patients with occult GI bleedingand negative SBCE was found to be significantlylower (4.6 %) compared with those with apositive SBCE (48 %) [21].

This information will be covered in detailin the chapter on PillCam small bowel.

2.1.4 Crohn’s Disease

SBCE is an important tool both in the diagnosisand in the follow-up of Crohn’s disease. It isused to establish the diagnosis, to assess diseaseextent, severity, and disease activity, and toassess mucosal healing post-therapy (Fig. 2.6).

SBCE has a high diagnostic yield in suspectedCrohn’s disease. Moreover, for both known andsuspected Crohn’s disease, SBCE was found to


have a better incremental yield (ranging between15 and 44 %) compared with other modalities,including small bowel follow-through, computedtomography, MRI, ileo-colonoscopy, and pushenteroscopy [21]. Increase in the diagnostic yieldof SBCE can be achieved by selecting patientswith high pretest probability such as those withperianal disease and negative work-up, using theinternational conference on capsule endoscopy(ICCE) selection criteria and/or patients with highfecal calprotectin level.

SBCE may alter disease management ofpatients with known Crohn’s, by assessingmucosal healing after medical therapy. SBCE isthe only method, except for double-balloon ent-eroscopy, to accurately assess small bowelmucosal healing. SBCE was also found to beclinically useful for categorizing patients withindeterminate colitis, although negative SBCEstudy did not exclude further diagnosis of Crohn’s.

The rate of SBCE retention in patients withsuspected Crohn’s disease is similar to the gen-eral population (1.4 %), but retention rates ofmore than 8 % were reported in patients withestablished Crohn’s disease.

2.1.5 Small Bowel Tumors

The introduction of SBCE had resulted in dou-bling the rate of diagnosis of small bowel tumorsto 6–9 % of patients undergoing SBCE for vari-ous indications, obscure GI bleeding being themost common indication. More than half of thetumors diagnosed were malignant. Adenocarci-noma is the most common malignant tumor, fol-lowed by carcinoids, lymphomas, sarcomas, andhamartomas [22]. Gastrointestinal stromal tumorsare the most frequent benign neoplasm (32 % ofall cases). Melanoma is the most common tumormetastasizing to the small bowel, althoughmetastases derived from colorectal cancer andhepatocellular carcinoma have also been repor-ted. Tumors are located most frequently in thejejunum (40–60 %), followed by the ileum(25–40 %), and the duodenum (15–20 %). Smallbowel tumors can be easily missed due to thepredominant submucosal and extraluminal

Panel A: Active bleeding

Panel B: Angioectasia

Panel C: Small bowel ulceration

Fig. 2.5 Causes for small bowel obscure bleeding

10 Z. Li et al.

location of the tumors. Specific indexes and scaleswere developed for improving the detection rateof small bowel tumors, including the SmoothProtruding Index on Capsule Endoscopy (SPICEscore) and an automated scale using multiscalewavelet-based analysis [23, 24].

More details will be provided in thechapter on PillCam SB.

2.1.6 Celiac Disease

SBCE has a role in both the diagnosis of celiacdisease and in the evaluation of gluten refractoryceliac disease (Fig. 2.7). SBCE provides high-resolution magnified view of the mucosa, easilyidentifying the endoscopic changes found inceliac such as scalloping, mosaic pattern, flatmucosa, loss of folds, and nodularity. In a recentpublished meta-analysis, SBCE had an overallpooled sensitivity of 89 % and specificity of

95 % for identifying celiac disease [25]. Ingluten non-responsive celiac disease, SBCE canbe used for investigating the small bowel fortumors (enteropathy-associated T-cell lym-phoma and adenocarcinoma) and ulcerative je-juno-ileitis (Fig. 2.7).

2.1.7 Inherited Polyposis Syndromes

SBCE was shown to be effective tool in detect-ing small bowel polyps in Peutz–Jegher syn-drome. It is especially effective in demonstratingsmall- and medium-size polyps. However, largepolyps are sometimes only demonstrated par-tially, and polyp location is not accurate [26].The duodenum is a potential pitfall as the cap-sule passes it very fast and thus may give false-negative results. The new SB3 SBCE mayimprove that with its six frames per secondmode. Coupling of SBCE with double-balloon

Capsule Endoscopy Findingsof Crohn’sDisease

Fig. 2.6 Small bowel Crohn’s disease


enteroscopy and polypectomy may offer an idealmethod of follow-up and treatment of thesepatients, possibly avoiding surgery.

Another indication for SBCE in this setting isfamilial adenomatosis polyposis (FAP) in whichone may find patients with duodenal polyps, aswell as small bowel polyps. However, the majorpapilla is not demonstrated effectively, andcomplementary examination with a side-viewduodenoscope is mandatory.

2.1.8 Monitoring Effects and SideEffects of Drugs

SBCE can be used to monitor deleterious effectsof drugs such as NSAIDs on small bowelmucosa. Lesions that can be found in thesepatients include erythema, erosions, smallulcerations, and weblike strictures. SBCE can beused to monitor the effect of drugs used to pro-tect against NSAIDs-induced small bowelinjury, to monitor the small bowel mucosalappearance in transplanted patients, to managegraft versus host disease, and, possibly, tomonitor mucosal healing of small bowel Crohn’sdisease after various medical treatments.

2.1.9 Capsule Retention

Capsule retention is the major complication ofSBCE. Very rarely this may end in bowelobstruction/perforation. High risk of retentionoccurs in patients on NSAIDs, with knownCrohn’s, with radiation enteritis, or with smallbowel tumors. Normal prior radiological exam-ination does not always protect from havingcapsule retention. Once retention is diagnosed(capsule not excreted 2 weeks after ingestion),endoscopic (balloon-assisted enteroscopy) orsurgical removal was shown to be effective. Theintervention not only allows removal of thecapsule, but also allows the offendingabnormality.

2.1.10 Esophageal Video CapsuleEndoscopy

In 2004, Given Imaging developed an esophagealvideo capsule (PillCam ESO) as a noninvasivedevice for the examination of the esophagus. Thesecond-generation esophageal capsule, the Pill-Cam ESO2 (Given Imaging, Yokneam, Israel),was FDA-approved for marketing in 2007

Fig. 2.7 Typical PillCamSB findings in celiacdisease

12 Z. Li et al.

(Fig. 2.8). The esophageal capsule endoscope(ECE) is a 26 9 11 mm capsule that differs fromthe SBCE in a few parameters: It has opticaldomes on both sides, the frame rate is much faster(9 frames from each side versus 2), a wider angleof view (169 vs. 156�), more advanced optics (3lenses), and a shorter battery life of up to 30 min,all aimed to address the very short time (\2 s) ofesophageal transit as well as the necessity todemonstrate the esophageal–gastric junction,where most of the esophageal pathology is loca-ted. It works for approximately 30 min and thenshuts off and passed through the intestine viaperistalsis and is naturally excreted. As in PillCamSB 3 system, or PillCam Colon2, real-timeviewing is feasible.

Procedure: Prolongation of the transit time ofthe capsule has been achieved by an alteration ofthe capsule ingestion technique, using the sim-plified ingestion procedure (SIP) (Fig. 2.9), wherethe patient swallows the capsule after at least 3 hof fasting, lying in the right lateral position whilesipping 15 mL of water every 30 s through a straw[27]. The procedure requires up to 5 min in anunsedated patient. Thus far, no other esophagealcapsules are in the market. Competition includesattempts to attach a string to a Given Imagingsmall bowel capsule, the Given Imaging magneticcapsule, and the Olympus gastric capsule whichare maneuvered with a joystick (Fig. 2.10).

Indications for ECE:• Screening for Barrett’s esophagus• Surveillance of esophageal varices in patients

with portal hypertension.

ECE is safe, well tolerated, and reported to bepreferred by patients to unsedated EGD. ECEwas found to have variable sensitivity andspecificity for the detection of GERD-relatedcomplications. Few studies reported very highspecificity and sensitivity for the detection oferosive esophagitis and Barrett’s esophagus(Fig. 2.11) [28, 29], while others found muchlower rates of sensitivity and specificity. Arecent meta-analysis of seven studies involving446 patients, ECE was found to have a sensi-tivity of 86 % and specificity 81 % in detectingesophageal varices (Fig. 2.12) [30].

Further details will be given in the chapteron Esophageal Capsule Endoscopy.

ECE may be used as an alternative to con-ventional upper GI endoscopy for the diagnosisof varices in complex patients with portalhypertension. It is most useful in certain patientgroups: patients who poorly tolerate endoscopyor who have significant comorbidity, thusincreasing the risks of repeated endoscopy, andpatients with high risk of variant Creutzfeldt–Jakob disease.

Although the major innovations and techno-logical advancement, at this point of time, ECEis not recommended as initial screening tool forthe mentioned conditions, mainly due to thelower cost and higher availability of upperendoscopy.

2.1.11 Colon Capsule Endoscopy

Colon capsule endoscopy (CCE) (Given Imag-ing Ltd., Yokneam, Israel) was introduced in2006 for the diagnosis of colonic pathologies,mainly polyps and tumors. In 2009, it wentthrough major upgrading when the second gen-eration of the capsule was introduced(Fig. 2.13). The second-generation capsule isslightly larger than the SBCE (31 9 11 mm) andhas two camera domes with an adaptive framerate of 4–35 frames per second, a 172� viewangle for each camera, and longer life of up to11 h due to the addition of a third battery andadvanced engineering techniques. As men-tioned, the frame rate can reach up to 35 frames

Fig. 2.8 PillCam ESOcapsule endoscope


per second depending on the capsule movementspeed in the colon and is determined using therevolutionized adaptive frame rate technique viaa cross talk between the capsule and the datarecorder (DR3). This new recorder is endowedwith artificial intelligence that communicates

with the capsule, as well as with the patient bybeeping and vibrating when the capsule leavesthe stomach and displaying on the LCD screen amessage that informs the patient to ingest abooster laxative which will accelerate the pas-sage of the capsule through the small bowel.

Procedure: As in colonoscopy, bowel prep-aration is compulsory in order to achieve ade-quate mucosal visualization. This is done using astrict preparation that includes liquid diet on theday prior to capsule ingestion, two doses of 2 lof PEG solution (on the evening prior to inges-tion and on the morning of the capsule inges-tion), as well as propulsive agents to enhancecapsule movement in the small bowel andadvance it to and through the colon, while thebattery is still working.

The main indication for CCE is colonic polypdetection (Table 2.1, Fig. 2.14). Colonicscreening programs in moderate- and high-riskgroups reduced the incidence, morbidity, andmortality due to colorectal carcinoma. However,

ECE Ingestion Procedure:

Original

002

min

300

2 m

in60

01

min

Simplified

ECE propelled by water (15cc every 30 sec)

Patient ingests ECE while lying

on right side

Fig. 2.9 Ingestion procedure for PillCam ESO capsule endoscope

Fig. 2.10 String capsule device. Reprint with permis-sion from Ramirez et al. [32]

14 Z. Li et al.

compliance rates to colonoscopy screening pro-grams are hampered due to fear of the inva-siveness and possible complications. CCEallows visualization of colonic mucosa with aminimally invasive procedure using no sedation,insufflation, or radiation and a practically com-plication-free method for colorectal screening.

Because noninvasive colorectal imaging testscannot provide a histological diagnosis, mor-phological criteria (i.e., polyp/mass C6 mm insize, or C3 polyps) are accepted as surrogatemarkers of advanced neoplasia. The averagesensitivity of the first generation of CCE forsignificant findings (C6 mm size, or C3 polyps

Fig. 2.11 PillCam ESO pictures of Barrett’s (a) and esophagitis (b)

(a)

(d) (e) (f)

(b) (c)

Fig. 2.12 a–f Images of Esophageal varices taken with Pillcom ESO


irrespective of size) was relatively low, but itsignificantly improved with the use of the sec-ond-generation CCE (49).

Indications: The latest guidelines publishedin 2012 by the European Society of Gastroin-testinal Endoscopy (ESGE) [31] state that:• CCE is feasible and safe and appears to be

accurate when used in average-riskindividuals.

• In patients with high risk for colorectal car-cinoma in whom colonoscopy is not possibleor not feasible, CCE could be a possible study.

• CCE is also a feasible and safe tool for visu-alization of the colonic mucosa in patientswith incomplete colonoscopy and withoutstenosis.Another possible indication for CCE is in the

diagnostic work-up or in the surveillance ofpatients with suspected or known inflammatorybowel disease (IBD), especially ulcerative coli-tis. Further details can be found in the chapter onColonic Capsule Endoscopy.

2.1.12 Summary

Since its introduction almost 13 years ago, theclinical indications for the use of capsuleendoscopy have widened considerably. Capsuleendoscopy has been proven to be a useful min-imally invasive tool in the exploration of theentire gastrointestinal tract, allowing visualiza-tion of previously inaccessible parts andachieving worthy satisfaction from both physi-cians and patients. New indications and future

possibility to control the capsule movementenabling new possibilities for diagnosis andtargeted therapy will evolve with the futuretechnologic advancement.

2.2 EndoCapsule

The EndoCapsule (Olympus, Tokyo, Japan) is avideo capsule endoscopy for the small intestineusing a charge-coupled device sensor instead ofa CMOS to acquire images (Fig. 2.15). Laun-ched in Europe in 2005, EndoCapsule obtainedFDA clearance in 2007 [33]. The EndoCapsuleconsists of a camera, light source, transmitter,and batteries. Once the capsule is activated andswallowed by the patient, it begins transmittingimages of the digestive system to a receiverworn by the patient. After the examination, thepatient returns the receiver to the physician or anurse who can download all images to a com-puter and find the abnormalities in small intes-tine (Fig. 2.16).

2.2.1 Special Characteristics [34]

1. High-resolution CCD2. Smart Recorder: It combines a receiver and

viewer in a compact and easy-to-handle unit,allowing the physician to playback and cap-ture images any time during the procedure.

3. 3D Track Function: That function offersintuitive operation, showing capsule locationto help you decide what approach should betaken for subsequent procedures.

2.2.2 Preparation

The bowel preparation of Endocapsule exami-nation includes a 12-h fast prior to the proce-dure, the administration of 2 l of polyethyleneglycol (PEG) solution in the evening and 1 l30 min before the procedure.

Fig. 2.13 PillCam Colon2 capsule endoscope

16 Z. Li et al.

2.2.3 Clinical Studies

In a British retrospective cohort study, 70patients performed Endocapsule examinationusing either overview with express-selected (ES)or overview with auto-speed-adjusted (ASA)modes. The ES-mode software eliminates

images with no significant changes (comparedwith the previous frames) in the video. And theASA-mode software speeds up the fps of the CE

Spectrum of Findings:

Fig. 2.14 Pathologies found with PillCam Colon2 capsule endoscope

Fig. 2.15 The Endocapsule. Reprint with permissionfrom Ogata et al. [38]

Fig. 2.16 Small intestinal villi detected by the Endo-capsule. Reprint with permission from Cave et al. [36]


video when detecting repetitive images. Among40 (57 %) patients found with clinically signif-icant findings, 32 (80 %) were recognized withoverview function alone, while 39 (97.5 %)were recognized with overview function plus ESor ASA modes. The average reading time foroverview with ES mode (19 ± 5 min) was sig-nificantly less than for overview with ASA mode(34 ± 10 min) (p = 0.001). These new play-back systems can efficaciously reduce readingtimes of CE but need further evaluation in pro-spective multicenter studies [35].

Cave et al. carried out a multicenter random-ized comparison of the Endocapsule and thePillCam SB in the USA. Results showed thepositive percent agreement of 70.6 % and anegative percent disagreement of 82.4 % with anoverall agreement of 74.5 %. The overall agree-ment was 74.5 % (38/51) with a j of 0.48 andP = 0.008. The study demonstrated that Endo-capsule had a similar diagnostic yield and betterimage quality compared with PillCam SB [36].

In another randomized head-to-head com-parison study in Austria, 50 patients were ran-domly assigned to swallow either the MiroCamfirst, followed by the EndoCapsule 2 h later, orvice versa. The MiroCam and EndoCapsuledevices were not statistically different withregard to their rates of complete small bowelexaminations (96 vs. 90 %) or diagnostic yield(50 vs. 48 %). However, the findings wereconcordant in 68 % only (kappa = 0.50). Thecombined diagnostic yield was 58 % [37].

2.3 OMOM Capsule EndoscopyPlatform

2.3.1 Overview

The creation of capsule endoscopy provides anew method for the visualized diagnosis ofdigestive diseases. It fixes the deficiency of thevisualized diagnosis of small bowel diseases andbrings a development direction of noninvasive,convenient, safe, and comfort diagnosis.

OMOM capsule endoscopy system is devel-oped by Chongqing Science and Technology(Group) Co. Ltd. Comparing with other similarproducts, the unique feature of duplex multi-channel communication mode has largelyincreased the controllability and convenience inits clinical use. Through the verification ofclinical application, the product has equalvalidity and yield rate comparing with othersimilar products from overseas in the diagnosisof small bowel diseases, such as obscure GIbleeding, Crohn’s disease, small bowel tumor,and small bowel polyp [39–41].

Since the first generation of OMOM capsuleendoscopy successfully created in 2004, Chon-gqing Jinshan Science and Technology has beendedicated to provide comprehensive solutions inthe diagnosis of digestive diseases. Based on thefirst generation of capsule endoscopy, the com-pany has developed various new capsuleendoscopy products according to different clin-ical uses, such as controllable capsule endos-copy, storable capsule endoscopy, and CCE, inwhich it can provide safe, noninvasive, comfort,and convenient visualized diagnosis for thewhole digestive tract.

After nearly 10 years of development,Chongqing Jinshan Science and Technology inthe field of digestive medical area has launcheda series of high-end products according to dif-ferent clinical uses, in which they are able toprovide accurate diagnosis of digestive tractdisease with comprehensive and personalizedsolutions. The following article will describe indetail about the application range, product for-mation, functions, and features of the products.

2.3.2 Small Bowel Capsule Endoscopy

OMOM small bowel capsule endoscopy ismainly used for visualized diagnosis of smallbowel diseases. It is a new diagnosis methodwhich is noninvasive, painless, safe, and com-fort. After swallowing the capsule, it will passthrough esophagus, stomach, duodenum, jeju-num, ileum, and colon and finally expel fromhuman body naturally by digestive tract

18 Z. Li et al.

peristalsis. The capsule will continuously cap-ture images of the GI tract during its movementprocess and transmit real-time image datawirelessly to the external image recorder. Afterthe monitoring process, doctors can replay andanalyze the saved images through the imageworkstation and finally make diagnosis of thegastrointestinal illness.

Small bowel capsule endoscopy system ismainly comprised of three parts: capsule, imagerecorder, and image workstation (Fig. 2.17), andfunctions of each part are described below:

Capsule: Capturing real-time image of GItract and transmitting image wirelessly to theexternal image recorder; meanwhile, it is able toreceive control signal from the image recorder toadjust working parameter.

Image recorder: Receiving and saving digi-tal images from the capsule; also, it is able tosend control signal to adjust the workingparameter of the capsule.

Image workstation: Man–machine interac-tive operation platform can monitor the workingcondition of the capsule in real time andadjusting its working status. It is able to down-load and replay image data from the imagerecorder, assisting doctors to make diagnosis.

Indications:1. GI hemorrhage, with no positive finding in

upper and lower GI tract endoscopicexamination;

2. Small intestine imaging anomaly suggestedby other examinations;

3. Any type of IBDs, excluding bowel obstruction;4. Unexplained abdominal pain and diarrhea;5. Small intestine tumor (benign, malignant,

carcinoid, etc.);6. Unexplained iron-deficient anemia.

Contradictions:1. Patients who are confirmed (or suspected) to

suffer from digestive tract malformation,gastrointestinal obstruction, gastrointestinalperforation, stenosis, or fistula;

2. Patients implanted with pacemaker or otherelectronic devices;

3. Patients suffering from severe dysphagia;4. Patients suffering from acute enteritis or

severe iron deficiency, for example, bacillarydysentery at active phase and ulcerativecolitis at acute phase, particularly for patientssuffering from fulminant diseases;

5. Patients allergic to polymer material;6. Use with caution for patients below 18 and

above 70 and for psychopath;7. Pregnant woman.

2.3.2.1 Features• Pioneer of duplex communication

It supports duplex data transmission betweenthe capsule and the image recorder. The real-time monitoring function, which can check thecaptured images in real time during the

Fig. 2.17 Small bowel capsule endoscopy system formation


examination, can able to make intuitive judg-ment about the location of the capsule within theGI tract. At the same time, it can control theparameters of the capsule, such as capture fre-quency, brightness, and exposure, in order toextend the monitoring time (Fig. 2.18). Thisfunction has been widely spread in clinical use,and it can increase the completion rate of smallbowel examination up to 100 % [42, 43].• Unique multichannel mode

OMOM capsule endoscopy system supportssimultaneous activation of multiple capsules atthe same place, without interference betweeneach of the capsules. Currently, OMOM capsulehas 10 channels, which means it can undertake10 patients simultaneously at the same locationin the hospital without interference betweeneach other. The image workstation can simulta-neously monitor images from four capsules inreal time (Fig. 2.19).• Unique wireless USB monitoring

The wireless USB monitor is a convenienttool. It enables wireless communication, real-time monitoring, and capsule working parameteradjustment between the image recorder and theimage workstation.

2.3.2.2 Clinical ApplicationSince 2005, OMOM capsule endoscopy hasbeen used in clinic for over 8 years, and it hascompleted over 1 million samples. Clinicalcontrast study shows that OMOM capsuleendoscope comparing with PillCam SB byIsraeli company Given Imaging has no signifi-cant differences in the diagnosis of small boweldiseases, such as obscure GI bleeding, vascularmalformation, small bowel tumor, small bowelpolyp, and Crohn’s disease [44]. In addition,during the clinical use of OMOM capsule, itsspecial feature of duplex communication func-tion that enables real-time adjustment of imagecapture frequency can achieve 100 % comple-tion rate of small bowel examination [42].

In 2,400 patients who had OMOM capsuleexamination [45], the diagnostic yield of smallbowel diseases was 47.7 %. In all findings ofsmall bowel, 28.1 % was vascular malformation,18.9 % small bowel tumor, 10.4 % polyp, 7.9 %Crohn’s disease, 15 % mucosa injury and ulcers,5.2 % bleeding, 11.3 % parasite, diverticulum,and so on. Comparing with traditional clinicalmethods such as GI radiography and CT,OMOM capsule endoscopy can provide more

Fig. 2.18 Real-time monitoring and capsule working parameter adjustment

20 Z. Li et al.

intuitive and clear images of small bowel, whichis able to significantly increase the completesmall bowel examination rate (CSER) and yieldrate, and also, it provides more safety and reli-ability [46, 47]. At the same time, OMOMcapsule endoscopy can incorporate other diag-nostic methods such as double-balloon endos-copy in clinical use. It can further improve theCSER and yield rate, and it can help to confirmthe lesion position and features prior to the smallbowel surgery which is efficient to lower the riskand difficulty of the surgery, thus improving thesurgery succession rate [48, 49].

2.3.3 Controllable Capsule Endoscopy

OMOM controllable capsule endoscopy isdeveloped based on the small bowel capsuleendoscopy. It can not only be used for visualdiagnosis of small bowel, but can also achievemovement and angle control within the stomach.After swallowing the controllable capsule intothe stomach, an external controller can control

the capsule movement, posture, and angle fromoutside the body, which makes stomach exami-nation controllable and comprehensive. After thestomach examination, the capsule will enterduodenum, jejunum, and ileum through GI tractperistalsis, and after the complete visualizedexamination of small bowel, it will pass throughcolon and be expelled from the body naturally.The capsule will continuously capture imageswithin the stomach and small bowel during theexamination, and the images will be transmittedand stored into the external image recorderwirelessly. After the examination, doctors cananalyze the images and make diagnosis throughthe image workstation. The controllable capsuleendoscope has solved the problems of ordinarycapsule when undertaking stomach examination,such as large blind spot, insufficient observation,and high misdiagnose rate. It provides a pain-less, noninvasive, safe, and comfort method forstomach examination. Clinical study shows thatthe controllable capsule can achieve compre-hensive examination of stomach fundus, stom-ach antrum, stomach corner, and stomach body

Fig. 2.19 Real-time monitoring of four capsules


with high detection rate and low misdiagnoserate [50, 51].

Controllable capsule endoscopy system iscomprised of four parts: capsule, image recorder,image workstation, and controller (Fig. 2.20).

2.3.4 Storable Capsule Endoscope

Storable capsule endoscope uses a large capacitystorage module instead of traditional datatransmission module. The captured images willbe stored within the internal capsule memorymodule.

The advantages of storable capsule endo-scopes are as follows: Patients do not need towear an image recorder after swallowing thecapsule, and they only need to be aware of thetime of expelling the capsule from the body andcollecting it. Then, a unique data reading andimage viewing tool is used to process the imagesin order to make an analysis.

The storable capsule endoscope is disposable.The large capacity storage module contains8 GB of memory which can store over 120,000images. The working duration of the capsulereaches 15 h.

Storable capsule endoscope system is com-prised of three parts: capsule, data reader, andimage workstation.

Storable capsule endoscope is mainly usedfor the diagnosis of small bowel diseases such asunknown abdominal pain, GI hemorrhage, smallbowel tumor, and Crohn’s disease.

2.3.5 Colon Capsule Endoscope

Colon capsule endoscope is a painless, nonin-vasive, safe, and comfortable diagnose methodspecially designed for colon disease. Accordingto the physiological structure of colon and basedon traditional capsule endoscope, it augmentedmore features such as capsule controlling, posi-tion measurement, posture measurement, andadjustment. It can achieve to control the move-ment, posture, and position of the capsule withinthe whole colon. Colon capsule can be entered tothe colon through swallowing or anus insertion.The movement of the capsule can be fully con-trolled by the external controlling device. Thecapture images will be transmitted to the controlpanel in real time wirelessly, and adjust thecapsule posture and angle to ensure the com-prehensiveness and reliability of the examina-tion. Therefore, comprehensive diagnosis of thewhole colon can be achieved.

Colon capsule endoscope system is com-prised of three parts: colon capsule, controllingdevice, and control panel (Fig. 2.21).

Colon capsule endoscope system is mainlyused for the diagnosis of various colon diseasessuch as colon inflammation, ulcer, diverticulum,polyp, and tumor.

2.3.6 pH Capsule Wireless MonitoringSystem

Gastroesophageal reflux disease (GERD) is acommon digestive disease which affects10–20 % of European and American population[52], and this ratio is relatively lower in Asia, butit has an increasing trend [53]. Clinical researchshows that continuous pH monitoring withinesophagus is the most effective way of diagnosingGERD [54]. OMOM pH capsule wireless moni-toring system is mainly used to monitor the pHvalue inside the esophagus and make diagnosis ofGERD through detecting the change in pH value.

Fig. 2.20 Controller

22 Z. Li et al.

The pH capsule is sent and fixed on the mucosa ofthe esophagus through the catheter, and it willmonitor the pH value within the esophagus withthe sensor through 96 h of continuous examina-tion. The monitored data will be transmitted to theexternal data recorder wirelessly, and the doctorcan make diagnosis by analyzing the continu-ously monitored pH data parameter through theworkstation after the examination is completed.The capsule will naturally drop off from themucosa and finally expel from the body.

Clinical application research shows thatOMOM pH capsule wireless monitoring system issafe and efficient for diagnosing GERD. Longcontinuous monitoring time can reflect the statusof the gastroesophagus reflux, which leads to highGERD positive detection rate, and it can effec-tively evaluate the frequency and severity of thereflux [55]. Comparing with traditional pH mon-itoring method such as catheter-based monitoringand endoscopy, it has similar diagnosis effect, butwith easier and more convenient clinical opera-tion [56, 57]; also, long monitoring time of 96 h isnot only effective for GERD diagnosis in the earlystage, but also effective for assisting therapeuticdecision in the later stage, and it evaluates theeffectiveness of medical treatment.

pH capsule wireless monitoring system ismainly comprised of three parts: pH capsule(including the catheter), data recorder, and dataanalyzing software.

Indications:1. Patients have classic symptoms of acid reflux or

heartburn and are considered as GERD patients;2. Patients suffer from unexplained chronic

pharyngitis, hoarseness, trachitis, or asthmaand are considered as those having extra-esophageal symptoms of GERD;

3. Patients who are considered as GERD patientsand are positive in PPI therapeutic test;

Contradictions:1. Patients who are confirmed (or suspected) to

suffer from upper esophageal or nasopha-ryngeal obstruction;

2. Patients who are confirmed (or suspected) tosuffer from esophageal varices according togastroscopy, clinical radiology, or otherexaminations;

3. Patients who are confirmed to suffer fromesophageal mucosa erosion according togastroscopy or other examinations;

4. Patients who are confirmed (or suspected) tosuffer from congenital digestive tract mal-formation, gastrointestinal obstruction, andperforation, stricture, or fistula of digestivetract according to clinical radiology or otherexaminations;

5. Patients who had bleeding tendency or gas-trointestinal bleeding in the recent 6 monthsor have taken anticoagulant drugs for a longperiod of time;

Fig. 2.21 Colon capsuleendoscope systemformation


6. Patients who suffer from heart disease and arenot stable;

7. Patients implanted with pacemaker or othermedical devices;

8. Patients who had history of allergy to poly-mer material.

2.3.7 Impedance–pH MonitoringSystem

Impedance–pH monitoring system is used forthe diagnosis of GERD, which is an alternativemethod of pH capsule wireless monitoring sys-tem. The principle of this product is that itintegrated both pH sensor and impedance sensor.The sensors are sent to the esophagus throughnose by using a catheter, they will continuouslymonitor the patient’s pH data and impedancedata within the esophagus, and the data will betransmitted to the external data recorder. Doc-tors can analyze the changes of pH data andimpedance data through the workstation, inorder to make the final diagnosis. Throughclinical study, the added impedance monitoringcan not only increase the reliability of diagnos-ing GERD, but also detect alkaline reflux, whichis valuable for comprehensive GERD monitor-ing and evaluation in clinical use [58, 59].

Impedance–pH monitoring system consists ofthree parts: catheter, data recorder, and dataanalyzing workstation.

2.3.8 Conclusion

Capsule endoscope has provided a new methodof diagnosing GI diseases in clinical use. Themedical field calls it as the development trend ofGI endoscopy in twenty-first century, and itbrings the third revolution in GI endoscopydevelopment history. Its existence has made thedevelopment trend of GI disease diagnosistoward noninvasive, convenient, safe, andcomfort.

OMOM capsule endoscope has entered forclinical use since 2005, and in 8 years of clinicaluse and research, it has verified this product as

an effective method of visualized diagnosis forGI diseases. Comparing with similar productssuch as PillCam by Given Imaging, EndoCap-sule by Olympus, and MiroCam by Intromedic,OMOM capsule endoscope has same diagnosiseffect with lower price which is more acceptableand affordable for patients. Based on OMOMcapsule endoscope, Chongqing Jinshan Scienceand Technology has developed a series of newproducts according to the clinical use of visu-alized diagnosis in GI diseases, such as con-trollable capsule endoscope and colon capsuleendoscope. At the same time, it has developedproducts for diagnosing GI function disorders,such as pH capsule wireless monitoring systemand impedance–pH monitoring system which isable to provide comprehensive solutions for GIdisease diagnosis.

With the development of new technologiesand applications in the field of medical appli-cation, the future research and application of theGI diagnostic technology will mainly carry outin three directions: (1) the application of mult-isensing and detection technology for morecomprehensive diagnostic information; (2) thedevelopment direction from minimal invasive tononinvasive; and (3) the development directionfrom diagnosis to diagnosis–treatment com-bined. The capsule endoscope will eventuallydevelop from a diagnostic tool to a diagnosis–treatment-combined intelligent robot.

2.4 MiroCam

2.4.1 Background of Development

Since the first development of a wireless capsuleendoscope, M2A, the prototype of PillCam(Given Imaging Yokneam, Israel) in 2000 [60],it has been widely applied in clinical practice forthe investigation of small bowel disease. Cap-sule endoscopy is easily performed only byswallowing the pill-sized capsule and so over-comes the limitations of conventional endoscopy

24 Z. Li et al.

such as highly uncomfortable process, thenecessity for skilled physician, and variedquality or outcome of examination depending onthe physician’s skill. Followed by M2A, othercompanies competitively released new capsuleendoscopes in the market: Endocapsule EC type1 (Olympus Ltd., Tokyo, Japan) in Japan [61]and OMOM (Jinshan Science and TechnologyCompany, Chongqing) in China [62]. Eventhough there is a little difference in detail specs,these capsule endoscopes adopted the sametransmission system, radio frequency (RF), forexporting imaging data to the receiver. RF sys-tem made wireless capsule endoscopes possible,but this system is energy-consuming, whichlimits the operation time of capsule endoscopesand complete examination up to cecum.

MiRo capsule endoscope, which was intro-duced in Korea in 2007 [63] and prototype ofMiroCam, is the smallest and lightest capsuleendoscope with the longest operation time up to11 h by using distinctly different transmissionsystem and human body communication. Miro-Cam was approved for general clinical use inEurope in August 2007 and by the US Food andDrug Administration (FDA) in June 2012.

2.4.1.1 Specifications of MiroCamGenerally, capsule endoscope systems have threecomponents: a capsule endoscope body, anexternal receiving antenna with attached portablehard disk drive (data recorder), and a customizedPC work station with dedicated software forreview and interpretation of images [64]. Miro-Cam capsule is a pill-sized endoscopic bodyconsisting of lens, imaging sensor, light source,power source, and telemetry device (Fig. 2.22).

Characteristics of MiroCam

The MiroCam is 10.8 9 24 mm, smaller thanPillCam at 11 9 24 mm and weighed 3.3 g [65].It has an image field of 150� and resolutionpower of 320 9 320 pixels, which is a signifi-cant improvement over the 256 9 256 pixels inthe PillCam. It includes a sensitive, low-powerCMOS image sensor converting the optical raysto electrical voltages and a white-light-emitting

diode (LED) as the illumination source. Twoserial silver oxide batteries are used as a powersource and operate for 9–11 h.

A Novel Transmission System and Human

Body Communication with Electric Field

Propagation

For imaging transmission, conventional endo-scopes have a direct signal path, such as a con-ductive wire between the camera and datarecorder. But capsule endoscope systems needwireless transmitter that delivers the imagingdata to a receiver outside of the body. The basictelemetry system of capsule endoscope is com-posed of three elementary components [65]. Thetransmitter, at some location in space, convertsthe message signal produced by a source ofinformation into a form suitable for transmissionover a channel. The channel, in turn, transportsthe message signal and delivers it to a receiver atsome other location in space [67].

For the wireless transmission, the standardcapsule endoscope uses RF communicationtechnology. But RF system has a drawback ofsevere power consumption as follows. A localoscillator makes a very-high frequency carrier,and an amplifier lets signal transport high power.In addition most energy generated from trans-mitter is lost because of radiation characteristicsof RF energy [65]. Instead of this power-con-suming technology, MiroCam adopted novelhuman body communication technology knownas electric field propagation, which is patent inthe USA [67]. This technology uses the humanbody as a semiconductor for data transmission,and an elective field can be induced and conse-quently generates drift current, even though thebody has poor conductivity compared with ametal wire [65]. A space-occupying additionalantenna or high-frequency circuit for remotecommunication is useless in MiroCam, and only

Fig. 2.22 MiroCam(MC1000)


simple physical structure as a pair of gold platescoated on the surface of the capsule is enoughfor transmission.

Advantages of MiroCam

MiroCam overcomes inferior image quality ofconventional capsule endoscopes that is inevi-tably caused by data compression for efficientdata transmission under RF module. Blurring atedges of objects and of small or thin objects mayhinder detection of mucosal lesion [64]. How-ever, MiroCam with human body communica-tion does not need data compression, whichresults in more precise images (Figs. 2.23, 2.24).In the first clinical trial, the fine structures of thebowel mucosal surface, including villi and vas-culature of the entire small bowel lumen, couldbe observed without blurring or distortion inmore than 90 % of cases [65].

MiroCam dramatically reduced power con-sumption in various ways. Firstly, human bodycommunication consumes less power comparedwith RF by making the high-frequency modu-lation process unnecessary. Secondly, theCMOS image sensor was designed to minimizepower consumption, and thirdly, the telemetrychip and image sensor were combined on one

chip to reduce the current required for fan-outbetween chips. With this advantage, the capsuleoperation time prolonged up to 11 h only withtwo usual silver oxide batteries, and thereby,MiroCam improves the complete ratio to explorethe entire small bowel [68].

Other functional equipments could be put inplace where the additional antenna and high-frequency circuit of RF had been occupied,because these devices became unnecessary inhuman body communication. Capsule endoscopewith the function of biopsies, drug delivery, orlocomotive guidance will soon be realized.

2.4.1.2 Clinical Studies of MiroCam

Clinical Studies for the Diagnostic Feasibility

and Safety

• First clinical study of diagnostic feasibilityand safety of the prototype of MiRo capsuleThe first clinical study for safety and diag-

nostic feasibility of MiRo capsule endoscopewas reported in 2009 [65]. This study verifiedthe safety of the MiRo capsule in human beings,especially with regard to the cardiac and neu-romuscular systems, and evaluating the validityin the diagnosis of human small bowel. All 45

Fig. 2.23 Endoscopic images of normal lesions takenby MiroCam. a Esophagus. b Esophageal–gastric junc-tion. c Body of stomach. d Pylorus of stomach. e Small

bowel. f Lymphoid hyperplasia of terminal ileum. g Ileo-cecal valve. h Appendiceal orifice of Cecum

26 Z. Li et al.

volunteers experienced no adverse effects, andthere was no disturbance on one’s daily life. Allcapsule endoscopes were expelled within2 days, and the mean total duration of imagetransmission was 9 h 51 min (5 h 35 min–11 h).Complete exploration of the entire small bowelwas achieved in all 45 volunteers. In 68.9 %, theimages were fine and sophisticated and revealedmicrostructures over more than 75 % of theentire small bowel. The image quality was gra-ded as good or better in 91 %.• Safety of MiroCam in patients with cardiac

devicesPatients with cardiac pacemakers or

implantable cardiac defibrillators always requiretheir attention to environmental electromagneticinterference (EMI) which may cause seriouscardiac device dysfunction. By the same reason,capsule endoscopy should be performed care-fully in these patients due to EMI produced byelectrical signals of capsule endoscope when thecapsule wirelessly transmits endoscopic imagesto a receiver outside the patient’s body. For thisreason, the US FDA considers the presence of acardiac pacemaker or ICD as a relative contra-indication for CE.

When capsule endoscope operates, EMI withcardiac devices may occur by oversensing orundersensing the electric signal. Oversensingmay be developed by the radio frequencies of434 MHz pulsed with 2 or 4 Hz used in capsuleendoscopy as a transmission method, becausethe frequency is equivalent to a heart rate of 120or 420 beats/min that represents slow ventriculartachycardia to ventricular fibrillation [69].Therefore, cardiac devices may recognize it asnonexisting heart signals and inhibit ventricularpacing, which may cause bradycardia andsymptomatic dizziness or syncope. Moreover,inappropriate shock or antitachycardia pacingcould occur if an ICD detects an electric signaloriginating from a capsule endoscope. On con-trary, undersensing may result in competitionwith native QRS complexes. If cardiac devicecannot recognize the actual heart signal, it failsto deliver an appropriate therapy with potentialinduction of asynchronous ventricular or noise-mode function and tachyarrhythmia will con-tinue. However, these effects have not beenobserved to this time in vitro or clinical studiesof conventional capsule endoscope [69–76].Because, the vector of RF transmission with

Fig. 2.24 Endoscopic images of abnormal lesions takenby MiroCam. a Gastritis. b Gastric erosion with adherentblood clot. c Duodenal polyp. d Duodenitis with

erosions. e Small bowel ulcer. f and g Small bowel ulcerwith stricture. h, Colonic diverticuli (arrow)


capsule endoscope is mostly within the abdo-men, where is far from the location of the car-diac devices [71].

MiroCam equipped other transmission sys-tems instead of RF, and it may be affected by anadditional source of interference. Because thismethod uses the human body as a conductivemedium for transmission of endoscopic images,an actual electric current flows directly into theheart and skews the signals of cardiac devices.However, energy generated from MiroCam isonly 0.0225 J, which is weaker than0.5 * 360 J of cardiac device. Power of mobilephone that caused significant disturbance ofcardiac devices was 2 W, and it is 2 9 106 timesstronger than 1uW of MiroCam. Moreover, fre-quency of cardiac devices, 0.5 * 5 Hz, is quitedifferent to 1.5 * 3 MHz of MiroCam.

Based on these theories, clinical study wasconducted in six patients with three pacemakersand three implantable cardiac defibrillators [77].No disturbance in cardiac devices or arrhythmiawas detected on telemetry monitoring duringcapsule endoscopy. No significant changes in theprogrammed parameters of the cardiac deviceswere noted after capsule endoscopy. There wereno imaging disturbances from the cardiac devi-ces on capsule endoscopy. Capsule endoscopewith human body communication was safelycompleted in patients with cardiac devices inthis study, however, in which, only small num-ber of patients and limited types of cardiacdevices were included. Therefore, it is recom-mended that capsule endoscope should be per-formed under continuous ECG monitoring in ahospital setting after cardiac assessment bycardiologists. And further study is in need ofverifying the safety of capsule endoscopy in alarge number of patients with various types ofcardiac devices.

Comparative Studies with the Conventional

Capsule Endoscopes

Several studies were conducted to compare thediagnostic yield and complete examination ratebetween MiroCam and other capsule endo-scopes. While studies showed no statistical sig-nificance in difference of performance between

MiroCam and other capsule endoscopes, a trendfor the MiroCam to detect more small bowellesions than with the other capsule endoscopeswas observed.

The pilot study of sequential capsule endos-copies using MiroCam and PillCam showedcomplete examination rate 83.3 % in MiroCamand 58.3 % in PillCam (p = 0.031) [68]. Diag-nostic yields for MiroCam and PillCam were45.8 % and 41.7 % (p [ 0.05), respectively.The agreement rate between the two capsuleswas 87.5 % with a j value of 0.74.

In French multicenter study, 83 patients withobscure GI bleeding were enrolled and ingestedthe two capsules at a one-hour interval [78]. Afteranalyzing 73 cases (10 technical issues), therewere 30 concordant positive cases (41.1 %), andthe diagnostic concordance between the twosystems was satisfactory (j = 0.66). The finaldiagnosis was different in 12 patients (16.4 %)with nine positive findings only on MiroCam, twopositive findings only on PillCam, and one dif-ferent diagnosis in one patient. MiroCam andPillCam identified 95.2 and 78.6 % of positivecases, respectively (p = 0.02). The significantdifference may be explained in part by the longertransit time and the higher number of imagesproduced. But there was no significant differenceon image quality, field depth, and lighteningbetween MiroCam and PillCam.

Another multicenter comparative study wasperformed in six academic hospitals in USA andenrolled 105 patients with obscure GI bleeding[79]. The result showed an overall agreement of78.7 % (95 % CI, 68.7 * 86.6 %), a positiveagreement of 77.4 % (95 % CI, 58.9 * 90.4 %),and negative agreement of 79.3 % (95 % CI,66.7 * 88.8 %). Twelve abnormal findingswere observed only in MiroCam, and seven wereobserved only in PillCam. MiroCam had a 5.6 %higher rate of detecting small bowel lesions(p = 0.54). On average, MiroCam took 6.6 h toreach the cecum, which is longer than the timetaken by PillCam, i.e., 5.2 h (P \ 0.0001). Thisdifference in small bowel transit time may beexplained by the difference of the dimension oftwo capsules (10.8 vs. 11.0 mm). It was assumedthat the smaller MiroCam may be sufficiently

28 Z. Li et al.

large to ultimately be propelled through the smallbowel; However, there may be some slippagewith each peristalsis that causes the MiroCam tohave a longer transit time in small bowel [79].Despite longer transit time, the MiroCamachieved higher complete ratio than PillCam(93.3 vs. 84.3 %, P = 0.1)

To compare MiroCam and Endocapsule, atotal of 50 patients with obscure GI bleeding,chronic diarrhea, and anemia of unknown originparticipated in the clinical study in Austria [80].Complete small bowel examination wasachieved in 96 % patients using MiroCam and90 % patients using EndoCapsule (odds ratio2.67, 95 % CI, 0.49–14.45, p = 0.38). Diag-nostic yield in the small bowel was 50 % inMiroCam and 48 % in EndoCapsule withoutstatistical significance (OR 1.08, 95 % CI,0.49–2.37, P [ 0.99). The diagnostic concor-dance rate between the two different capsuleendoscopes was 68 % (j = 0.50).

Summarizing these comparative studies,MiroCam detects small bowel abnormalities at arate that is at least comparable to that of othercapsule endoscopes (Table 2.2). The longeroperational time of the MiroCam resulted in ahigher rate of complete small bowel examina-tion. Although statistical insignificance, the lar-ger numbers of images generated at three framesper second increased the detection rate of smallbowel lesions [79].

2.4.1.3 Upgraded MiroCamand Advanced CapsuleEndoscope

Upgraded model of the MiroCam (MC1000-W)has plans to market. The field of view of newmodel is improved to 170� compared with 150�of previous model (MC1000) (Table 2.3). Thesize is minimally changed from 10.8 9 24 mmto 10.8 9 24.5 mm, and the weight is reducedfrom 3.3 to 3.25 g. Resolution power of320 9 320 pixels and frame rate of three framesper second are identical with previous model.Operating time over 11 h is maintained, andtransmission method is same as human bodycommunication using E-field propagation.

External receiver was upgraded to wire–wireless real-time viewer, and data transmissionrate was two times higher. MiroView softwarewas also upgraded from version 1.0 to 2.0(Fig. 2.25). Rapid detection of bleeding focus bymap view became available, and reading timecould be markedly decreased by reading manyimages at a time using range view. Softwaresystem divided by sever, client, and operatormakes reading easier anywhere and anytime viainternal network of the hospital. Exporting pro-gram of the final report to the hospital imageprogram such as PACS was also improved.

Capsule Endoscopes with Active Movement

The movement of capsule endoscopes entirelydepends on the natural peristalsis of GI tract,which might be a main reason to prolong thegastrointestinal transit time. The uncontrollablemovement of capsule endoscope might beobstacles to reach the cecum within capsuleoperating time and to make accurate diagnosis.Therefore, techniques for active control of thecapsule movement have been being developed,such as a magnetic steering mechanism byexternal manipulation [81–87] and a locomotivemechanism by internal manipulation [88–91].• Magnetic steering capsule endoscope

(MiroCam Navi)MiroCam Navi (MC1000-WM) is one of the

magnetic steering capsule endoscope, which wasapproved for clinical use in Europe. Observingthe images on real-time viewer, magnetic cap-sule endoscope could be manipulated to moveup and down by MiroCam Navi controller out-side the body (Fig. 2.26). With MiroCam Navi,gastric transit time might be shortened, and thesmall bowel lesion could be observed in moredetail. Moreover, targeted drug delivery will berealized with this ability to operate freely in thenear future.• Paddling-based locomotive capsule

endoscopeFor internal locomotive devices, paddling-

based capsule endoscope has been developed.When a locomotive robot was suggested byHirose [92], Pratt [93], and Ryu [94], it was


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30 Z. Li et al.

Table 2.3 Comparisons of MiroCam (MC1000) to upgraded MiroCam (MC1000-W)

MC1000 MC1000-W

Image

Size (mm) 10.8 9 24 10.8 9 24.5

Weight (g) 3.45 3.25

Pixels 320 9 320 320 9 320

Frames per second 3 3

Field of view (�) 150 170

Operation time (h) Over 11 Over 11

Communicationmechanism

Electric field propagation Electric field propagation

Fig. 2.25 UpdatedMiroView (2.5)

Fig. 2.26 MiroCam Navi(MC1000-WM)


difficult to miniaturize the proposed leggedmechanisms, and thus, that was not applied tocapsule locomotion. In 2004, Menciassi pro-posed a legged locomotion in gastrointestinaltract [95], and with this 8-legged capsule, a fullcolonic passage was successfully demonstratedin the ex vivo phantom model [90]. However,the multilegged locomotion capsule needs mul-tiple actuators and controllers, which limitedminiaturization and energy conservation.

An inchworm-like microrobot comprisingactuation modules and clamping modules forcapsule endoscopes has been proposed in Koreain 2004 [96]. However, spring-type SMA actu-ators in this inchworm-like microrobot were notenough to get over resistance force of smallbowel and to realize long stroke with high effi-cacy [97–100]. In order to solve this problem, anew paddling-based locomotive mechanism wasdeveloped in 2006 [101]. This locomotivemechanism is originated from paddling a canoe.The paddle of a canoe is embodied as the legs ofour microrobot, and the canoeist is replaced bythe linear actuator which is composed of a reli-able commercialized micromotor and a leadscrew. And the more enhanced paddling-basedlocomotive CE was presented in 2010 anddemonstrated its efficacy in vitro and in vivoexperiments [102].1. Concept design of the microrobot

At first, the paddling-based locomotive mi-crorobot consists of a linear actuator whichcomprises micromotor and lead screw, an innercylinder, an outer cylinder, multiple legs, androbot outer body [101]. The functions of thisnovel microrobot are illustrated as follows[101]: (1) The linear actuator moves the innercylinder backward and forward. (2) The innercylinder has grooves, and there is some clear-ance between the grooves and the legs. Owing tothe clearance, the inner cylinder makes the legsrotate and moves the legs and the outer cylinder.(3) The outer cylinder is connected with themultilegs by wire-type pin and is moved insideof the robot outer body. (4) The multilegs areprotruded out of the robot body and are folded inthe robot body. The microrobot has six legswhich are radially positioned and are in contact

with the intestinal surface. (5) Finally, in orderto reduce the frictional force between the robotouter body and the intestinal surface, the head ofthe microrobot is designed as a semisphere andthe robot outer body is coated with lubricantsuch as silicon oil. And for the protruding andfolding the legs, the microrobot outer body hasthe lateral slits.

In the modified locomotive capsule endo-scope, outer ring is added to generate continuousfriction between the outer body and the outercylinder and to provide robustness in the kine-matic configuration, such as the positional dif-ference between the inner and the outercylinders for protruding or folding paddles [102](Fig. 2.27). As a result, the capsule endoscopecan satisfactorily move inside the GI tract duringrepetitive movements. Moreover, this CE isteleoperated by the automatic controller, withwhich a reciprocating cycle for the cylinders ofthe capsule endoscope can be moderated bysetting desired cycle time using a microproces-sor on the controller [102]. This automaticcontrol mechanism reduces power consumptionand accelerates locomotion compared with themanual switching for the control used in theprevious locomotive capsule endoscope [101].2. Locomotive mechanism of the proposed

microrobotLocomotive mechanism is illustrated in

Fig. 2.28. By repeating paddling motion, thiscapsule moves forward in the GI tract [102]. Forthis, the paddles linked to the outer cylinder areprotruded and folded according to the directionof linearly actuating the inner and the outercylinders along the lead screw. The clearancebetween inner and outer cylinders causes

Fig. 2.27 Concept design of paddling-based locomotivecapsule endoscope (Reprint with permission from Kimet al. [102])

32 Z. Li et al.

relative position delay of the outer cylinder tothe inner one during linear motion. As a result,the paddles rotate on pivotal points for pro-truding or folding when multiple grooves innercylinder relatively push the end of paddles toright or left, as shown.3. Specification of modified paddling-based

locomotive capsule endoscopeThe locomotive capsule endoscope is

15 9 43 mm in size and weighs 14 g. Thelength of the slit, meaning an actual strokelength of paddles for advancing, is 33 mm. Acamera module is located in front of the

locomotive capsule endoscope and had a field ofview of 125 and resolution power of 320 9 320pixels. The capsule endoscope transmits videoimages at 10 frames per second to outsidereceiver. Two cables are connected to the end ofthe locomotive capsule endoscope for powersupply and locomotion control, and four cablestransmit image data from a camera. The cablesare extended to the external controller and therecorder, twisted as a bundle with a length of2 m from the end of the capsule endoscope.

The active movement of this novel capsuleendoscope with paddling-based locomotion wasdemonstrated in in vivo test with an anesthetizedpig [102]. The movement was fast and stablewith a regular velocity (17 cm/min over 40 cmlengths) set by the automatic controller. Andthere were no serious complications during itsactive movement.

Even this paddling-based locomotive capsuleendoscope has several advantages, such as longstoke, simple structure and control, and fastlocomotion, the present external controllershould be miniaturized and embedded in thecapsule endoscope. Moreover, a wirelesstelemetry system should be equipped for actualoperation and transmission of acquired imagesto recorder. A novel communication technologyusing human body communication [65] is a verysuitable method for developing a wireless loco-motive capsule endoscope due to its capabilityof energy conservation.

In the in vivo study, peristalsis seldom occur-red in colon of the general anesthetized pigs.Actually, peristalsis might disturb the activemovement of the capsule endoscope because thedirection of capsule endoscope is opposite to thatof peristalsis. Further study is needed to investi-gate the forward movement against provokedperistalsis by cholinergic drugs. Study aboutactual movement at anatomic obstacles, such asacute angles of recto-sigmoid junction or feces,should be evaluated. And further technologicimprovement should be achieved to use inhumans. A miniaturized steering module shouldbe developed to change a direction of CE and toview at specific directions.

Fig. 2.28 Locomotive mechanism of the paddling-based locomotive capsule endoscope (Reprint withpermission from Kim et al. [102]). a Initial state of thecapsule-type microrobot in the intestine. b When thelinear actuating mechanism starts to move the innercylinder backward, the paddles linked to the outercylinder are stretched, due to the kinematic relationshipbetween the inner and the outer cylinders, and clamp theintestinal surfaces. c While the actuator moves the innercylinder farther, the outer body of the capsule endoscopeadvances forward. d End of the stroke of the linearactuating mechanism. At this point, when the actuatingmechanism is about to move the inner cylinder forward,the paddles fixed to the intestine are released and foldedinto the capsule body as the above kinematic relationshipworks inversely. e The cylinders and folded paddlesreturn without the movement of the capsule body. f Thelocomotion principle returns to the same state in step A


• Self-stabilizing colonic capsule endoscopyThe smaller capsule is the better to swallow.

However, small bowel capsule endoscope tendsto tumble in larger-lumen organs such as stom-ach or colon [68, 103], which limits the visualfield causing failure to catch significant lesionsor grossly distorting the perceived dimensions ofpolyps [104]. Therefore, self-expanding capsuleendoscope after it enters into the bowel wasdeveloped to visualize the colon without tum-bling [105].

Self-stabilizing capsule endoscope is modi-fied from MiroCam capsule endoscope coupledto stabilizing component (Fig. 2.29). This sta-bilizing component was a thermally treated,woven, biodegradable, liquid-permeable, flexi-ble polyglactin 910 mesh (vicryl, Ethicon Inc.,Somerville, NJ) filled with super-absorbentpolymer granules (Favor PAC, Evonik Indus-tries, Stockhausen, Germany) [106]. Theexpandable material was salt granules ofhydrophilic, non-toxic, cross-linked polyacrylatepolymer. These granules can absorb severalhundred times their weight in water, but cannotdissolve because of their 3D polymeric networkstructure, and only the formation of a gel takesplace [107]. The advantages of this super-absorbent polymer as an expandable material forthe device are as follows; it is biocompatible,swells extensively, swells in a relatively shortperiod of time, exerts a reasonable swellingpressure on the walls of the lumen, and with-stands the pressure in the colon by remainingattached to the imaging component while keep-ing its consistency [105]. Moreover, theincreased viscosity of the surrounding liquid in

water allows the capsule to move smoothly inthe colon, and its flexibility is enough to passthrough sharp colonic turns such as the hepaticand splenic flexures [108]. This bending capa-bility should be uniform up to the base of theexpandable component that is attached to therigid but relatively small imaging component.

In living dogs, the study was conducted toevaluate the efficacy of this self-stabilizingcapsule endoscopy by quantitatively comparingthe detection rate of intraluminal suture markerlesions for colonoscopy [109]. Four mongreldogs underwent laparotomy and the implanta-tion of 5 to 8 suture markers to approximatecolon lesion. Each dog consecutively adminis-tered both unmodified capsule endoscope andself-stabilizing capsule endoscopy in randomorder by endoscopic insertion into the proximallumen of the colon. After capsule endoscopy,blinded standard colonoscopy was performed.The average percentage of the marker detectionrates for unmodified capsule endoscope, self-stabilizing capsule endoscope, and colonoscopy,respectively, was 31.1, 86, and 100 %(P \ 0.01). Self-stabilizing endoscope delivereda significant improvement in detection rates ofcolon suture marking when compared with theunmodified capsule endoscope, but there wereno comparisons of small bowel transit time.Further studies are needed for the safety andefficacy of the self-stabilizing capsule endoscopein human. The worrisome problem is a pre-mature expansion or obstruction in the smallintestine or stomach. And timed launching in thececum, detection of colon polyps, and imagingqualities should be investigated.

Fig. 2.29 Concept design of self-stabilizing capsuleendoscope (Reprint with permission from Filip et al.[105]). a Modified MiroCam capsule endoscope with

stabilizing component. b Fully expanded self-stabilizingcapsule endoscope

34 Z. Li et al.

2.5 The Ankon Magnetic-Controlled Capsule EndoscopyPlatform in the ClinicalInvestigation of StomachDiseases

Abstract Gastric diseases are great burden notonly in China but also worldwide. Capsuleendoscopy is a noninvasive tool in the explora-tion of the entire gastrointestinal tract. However,conventional capsule endoscopies have shownthat observation of the stomach is highly vari-able because of the impossibility of thoroughexploration of the gastric cavity with a passivepower. The steerable capsules with externalmagnetic field may be the most viable approa-ches for active control, and several explorationshave showed promising benefits. We havedeveloped a novel magnetic-controlled capsuleendoscopy system (MCE) with magnetic fieldgenerated by an external industry robot (pro-vided by Ankon Technologies Inc.), which hasbeen demonstrated to be safe and feasible in theexamination of human stomach. For the maindiagnostic outcomes, MCE and gastroscopy hadvery similar results (the overall agreement wasmore than 90 %). The acceptability of MCE wasmuch higher than gastroscopy, and most patientscould tolerate ingestion of the large amount ofwater. This comparative study showed that MCEis a promising alternative for noninvasivescreening of gastric diseases.

2.5.1 Introduction

Gastric diseases are great burden not only inChina but also worldwide [110–112]. Theprevalence of peptic ulcer disease confirmedendoscopically could reach to 17.2 % [113] inChina, substantially higher than in Westernpopulations. Gastric cancer remains the fourthmost common malignancy and the secondleading cause of cancer mortality in the world[114]. It is important to screen, diagnose, orexclude gastric diseases at an early stage. Gas-troscopy is the reference method for the

detection of gastric mucosal lesions. Unfortu-nately, it is widely regarded as uncomfortableand invasive for gastroscopy examination, thuswith low patient compliance [115]. Conscioussedation in endoscopy could have potentialdrug-related side effects and increase medicalcost, which limits its use in certain population[116]. Capsule endoscopy (CE) might offer amore patient-friendly alternative without dis-comfort or need for sedation. Since the first briefcommunication published in Nature in 2000introducing CE, it has rapidly become the cri-terion standard for small intestine examination[117–119]. However, for a large organ likestomach, the random movement of passivecapsule can let it observe only a small part of thewhole gastric mucosa.

Since the first case report of maneuverablecapsule system, published by Paul Swain et al in2010, endoscopy companies such as GivenImaging, Olympus, Siemens, and OMOM havedone some early-stage researches on this field.Capsule with propellers [120], paddles [121],and legs [122] has been studied with some suc-cess; however, a lot of work is still required forthese to become clinical reality. Through recentyears of efforts, the steerable capsules withexternal magnetic field may be the most viableapproaches for active control [123, 124], andseveral explorations (external magnet paddle orspecial MRI machine) have showed promisingbenefits [120, 125–128]. However, these systemsstill have some limitations. The magnetic forcegenerated by handheld external magnet appearedto be insufficient to prevent accidental emptyingof the capsule from strong retraction of pylori[125]. The equipment derived from magneticresonance imaging procedures provided ade-quate force and acceptable performance butindicated possibly fairly high cost [126].

Robotic control on magnetic capsule endos-copy based on industry robot may provide amuch more cost-effective solution. An in vivoanimal trial demonstrated that robotic control onmagnetic steering capsule was more precise andreliable than manual operation [127]. We havedeveloped a novel MCE system with magneticfield generated by an external industry robot,


which has been demonstrated to be safe andfeasible in the examination of human stomachby a pilot study of 34 healthy volunteers [129].

2.5.2 The ANKON MCE System

Ankon Technologies Inc. began its MCEresearch in 2009, and its NaviCam got SFDA’sapproval in China in 2013. The ANKON MCEsystem consisted of capsule endoscopy, a guid-ance magnet robot, a data recorder, and a com-puter workstation with software for real-timeview and control (Fig. 2.30).

The capsule endoscopy in stomach was per-formed well and safe in simulator model andporcine model. The capsule has a size of28 9 12 mm, which consisted of CMOS cam-era, LED, batteries, the magnet, RF transmitter,and magnetic and acceleration sensor. It has aview angle of 140� and a resolution of

480 9 480. The guidance magnet robot providesfive degrees of control freedom: two rotationaland three translational. The capture rate of MCEis two frames per second from a single CMOSsensor. It transmits images to the data recordervia a set of sensors placed on the patient’s skin.The images are viewed in real time on monitorand stored into workstation simultaneously.

The guidance magnet robot is of C-arm typewith five degrees of freedom. The completeworking area on the MCE is more than50 9 50 9 50 cm3. The magnetic field gener-ated by guidance robot system can be adjustedduring the examination and reach 200 mT atmaximum, which is much less than that fromstandard 1.5T MRI. Actual strength of magneticfield used to control the navigation of MCE isabout 5 to 30 mT, which is 60 to 300 timesgreater than the Earth’s magnetic field andgenerates magnetic force in the order of thecapsule’s weight. With permanent magnet, the

Fig. 2.30 The NaviCam MCE system

36 Z. Li et al.

guidance magnet robot runs very quiet andconsumes low electric power requiring nocooling system at all.

During examination, the doctor sits in front ofthe workstation with dual monitors. The leftmonitor displays the real-time view of stomachfrom the capsule and the view of patients fromcameras. The right monitor is the operatinginterface collecting the information aboutstrength of magnetic field, attitude of capsule,and so on. The ESNavi can also show the real-time location of capsule in the three-dimensionalmode. The attitude information of capsule isobtained through simulation on the basis of themagnetic field generated by the guidance sys-tem. MCE can be controlled by the magnetguidance robot through a joystick or automaticmode by which the MCE can make linearmovement or rotation without manual control(Fig. 2.31). The capsule could reach from thelower to the upper side of gastric wall, no matterwhat content the stomach is full of (water, air, orthe mixture). When the stomach is partially fil-led with water, the capsule can float stably at thewater level (Fig. 2.32).

2.5.3 Procedure

The patient arrived at the hospital between 8:00am and 10:00 am after fasting overnight ([8 h).All subjects drank 500 ml of clear water and5 ml simeticone about 1 h before capsuleingestion, another 500 ml of clear water 15 minbefore ingestion, and 6 g air-producing power(Tianzhili Biological Technology, Fuzhou,China) with 5 ml of water 5 min before inges-tion. The air-producing powder served to distendthe stomach through releasing about 540 ml CO2

every 6 g. After swallowing the MCE togetherwith 5 ml of water, the patient immediately liesdown on the bed attached to the guidance robot.The position of the bed was adjustable foroptimal gastric imaging and maximal magneticforce for capsule navigation.

During the examination, the patient lies downon the bed and kept minimum movement. Afterthe MCE reached stomach, the doctor moves thejoystick to control the movement of the mag-netic head based on the real-time images andparameters displayed on the operating interface(Fig. 2.33). The doctor performed the following

Fig. 2.31 Movements of the capsule

Fig. 2.32 a Floating view; b capsule under the water; and c capsule in the air


steps: lifting the capsule away from the posteriorwall, rotating and advancing the capsule to thefundus and cardiac region, then rotating capsuleto observe stomach body, and finally observingthe angulus, antrum, and pylorus. If the disten-sion was insufficient, ingestion of additional air-producing powder or water was repeated. Thewhole examination duration lasted for about30 min.

2.5.4 Indications

1. Patients with upper gastrointestinal symp-toms, including abdominal discomfort, pain,acid reflux, dysphagia, belching, and hiccups.

2. Screening for gastric cancer.3. Follow-up examination for gastric ulcer,

atrophic gastritis, and precancerous lesions.

2.5.5 Contraindications

1. Patients with impaired bowel movement fromileus or organic digestive diseases

2. Patients with known large and obstructingtumors of the upper GI tract

3. Patients after upper GI surgery or abdominalsurgery altering GI anatomy

4. Patients under full anticoagulation5. Patients in poor general condition6. Patients using equipment that may be affec-

ted by magnetic field, such as pacemakersand defibrillators

7. Pregnancy or suspected pregnancy8. Patients allergic to materials or drugs

involved9. Patients mentally ill or unable to cooperate.

In our pilot study of 34 healthy volunteers,the cleanliness was evaluated as good in 88 %subjects [129]. The distention of gastric cavitywas evaluated as good in the 85 % subjects.Maneuverability of the MCE to movements ofthe guidance magnet robot was graded as goodin 85 % subjects. More than 75 % gastricmucosa was visualized in 79 % subjects and50 % to 75 % in 20 % subjects. Visualization ofthe gastric cardia, fundus, body, angulus,antrum, and pylorus was subjectively assessed ascomplete in 82, 85, 100, 100, 100, and 100 %,respectively. No entire gastric mucosa wasobserved in all subjects for three reasons: (1)small amounts of fluid blocked the view of themost apical parts of the fundus; (2) insufficiency

Fig. 2.33 Capsulenavigation systemoperation

38 Z. Li et al.

of gastric distention; and (3) difficult for guid-ance MCE in the cardiac region. The removal ofmucus by drugs will need further researchesbecause it is a critical issue with regard to cap-sule navigation and visibility.

In another double-center comparative trial ofMCE and standard gastroscopy, both of themhad very similar results of the main diagnosticoutcomes (the overall agreement was more than90 %). The acceptability of MCE was muchhigher than gastroscopy, and most patients couldtolerate ingestion of the large amount of water.This study also showed that MCE is a promisingalternative for noninvasive screening of gastricdiseases.

In spite of initial and encouraging advance-ment in different kinds of MCE, there weremany concerns in its practical value at present[130]. The drawbacks of current MCE compar-ing with the standard gastroscopy are clear: (1)complicated gastric preparation; (2) lack ofbiopsy capacity; and (3) long examination time.However, in our view, all these drawbacks maybe solved in the future with the advancement oftechnology. As pointed by Rey, after balancingthe pros and cons of standard gastroscopy andMCE, the latter might be a more cost-effectiveuse of medical and social resources [126]. In thefuture, MCE may be adopted as the screeningexamination tool for gastric disease, especiallyfor the elderly with sedation contraindications.

2.6 CapsoCam

Two of limitations of capsule endoscopy are asfollows: (1) incomplete examination of the smallintestine due to inadequate battery life and (2)the inability to observe some areas on the sidewall because the camera is located at the end ofthe capsule [131]. The CapsoCam (Capsovision,Saratoga, CA, USA) was a recently developed11 9 31 mm capsule endoscopy, which repre-sents a new concept of detecting lesions in thesmall intestine: 360� panoramic lateral viewwith four cameras [132]. CapsoCam SV-1 cap-sule consisted of lens, imaging sensor, light

source, power source, and flash memory(Fig. 2.34). It has a high frequency of 20 framesper second during the first 2 h and thereafter 12frames per second, with a battery life of 15 h.

2.6.1 Special Characteristics

1. 360� Panoramic View: The CapsoCamemploys four cameras facing the sides of thecapsule that together image a full 360� aboutthe capsule’s circumference and capturehigh-resolution images of the mucosaincluding surfaces hidden behind folds.

2. Wire-Free Technology: There is no genera-tion and transfer of RF signals, and all theimages captured are stored on board withCapsoCam. The patient does not need anyform of external devices, and the clinician isfree of the receiver equipment and otheraccessories for data retrieval. However,because of not including the recording sys-tem, the capsule has to be retrieved by thepatient after expulsion in order for the videoto be downloaded.

3. Smart Motion Sense Technology: The SmartMotion Sense Technology allows the cam-eras to be activated to capture images onlyduring capsule motion. When the capsuledoes not move and is stationary, the sensor

Fig. 2.34 The CapsoCam SV1. Reprint with permissionfrom Friedrich et al. [132]


goes into the monitoring mode beforeswitching to active mode during motion,which also helps to conserve battery power.

2.6.2 Clinical Studies

Friedrich et al. firstly carried out a prospectivedual-center study of CapsoCam in Germany[132]. The study evaluated the feasibility andcompleteness of small bowel examination toge-ther with secondary end points of duodenalpapilla detection in 33 patients. Small bowelexamination was complete in all procedures.Mean time to pass the small bowel was258 ± 136 min. The duodenal papilla wasidentified in 71 % of the patients (Fig. 2.35). Noadverse effect was observed. It demonstratedthat CapsoCam is a safe and efficient tool insmall bowel examination.

To evaluate diagnostic concordance of thePillCam SB2 and CapsoCam capsules in the samepatients, a prospective comparative study wasconducted in four French referral endoscopy units[133]. Seventy-three patients ingested the twocapsules 1 h apart and in a randomized order.Results showed that concordant positive diagno-sis was 38.3 % and a negative diagnosis 43.3 %.The kappa value is 0.63, indicating that the con-cordance was good. In a per lesion analysis, theCapsoCam capsule detected significantly morelesions (108 vs. 85 lesions, P = 0.001). Readingtime was longer for CapsoCam procedures (32.0vs. 26.2 min, P = 0.002). This study shows

comparable efficiency of the CapsoCam andPillCam SB2 capsule systems in terms of diag-nostic yield and image.

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the current main types of capsule endoscopy

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