introducing the relief registry dr. jaron rabinovici sheba medical center, israel

INTRODUCING THE RELIEF REGISTRY

Dr. Jaron RabinoviciSheba Medical Center, Israel

Personal Experience with Focused Ultrasound

Performed the second uterine fibroid FUS treatment (First treatment at Harvard Medical School)• Participated in the first studies, pivotal study• Since then more than 300 uterine fibroid treatment at our Center

Treated the first patient who got pregnant after FUS• Published the first “pregnancy paper” on 52 pregnancies after

Introduced the possibility to treat adenomyosis • First study to demonstrate clinical efficacy and safety

Head of gynecological activity of Insightec Focused Ultrasound Center at Sheba Medical Center, Israel

Many invited lectures

© 2013 by Focused Ultrasound Foundation

Acceptance of Focused Ultrasound Treatment for Uterine Fibroids

Over the last decade ~ 10,000 treatments in ~ 100 centers!

Centers that managed to obtain some form of reimbursement managed to perform many procedures!


Problems in the Implementation of Focused Ultrasound for Fibroids

New technology• Physicians are conservative and “afraid” of new/unfamiliar approaches• Focused Ultrasound is available only in a limited number of centers• High “entry fee”• Need for good and extensive scientific data• Most data based on one center, limited observational studies• Need for extensive post-marketing experience• Lack of extensive long-term experience/data

Multiple Alternatives• Big competition, “difficult sale”

Treatment price• Limited adoption by insurance carriers


“Needed” Studies for Focused UltrasoundRandomized Controlled Studies?

RCT’s vs “gold standard” (which?)

• Difficult to impossible to perform.

• Random decision of invasive versus non-invasive treatment?

• Difficult recruitment, very expensive, variable results from various centers can affect outcome, examines a predefined patient population.


• Prospective entry of consecutive patients can provide data on clinical procedures – “real life”

• Able to gather data on many patients within a limited time frame and follow them up for a prolonged period of time

• The resulting reports and publications should provide a large body of evidence that will be difficult to disregard

“Needed” Studies for Focused UltrasoundRegistry Studies?


Gathering Evidence, Expanding AccessFocused Ultrasound for Uterine Fibroids

Registry Goal: Provide large scale evidence on safety, efficacy and long-term durability of Focused Ultrasound, to facilitate reimbursement and drive rapid patient and physician acceptance


REgistry for Leiomyoma: International Efficacy of Focused Ultrasound

3-year, single-arm, prospective, global registry 1,000 women treated with MR-guided FUS at 30+ treatment

sites Led by Steering Committee of international, leading experts Funded by philanthropy and industry


Steering Committee

Chair: Jaron Rabinovici, MD, Sheba Medical Center, Israel Anne Roberts, MD, University of California, San Diego Elizabeth A. Stewart, MD, Mayo Clinic, Rochester Robert K. Zurawin, MD, Baylor College of Medicine, Houston Elizabeth David, MD, Sunnybrook Health Sciences Centre,

Toronto, Canada Wladyslaw M. Gedroyc, MD, St. Mary's Hospital, London, UK Young-Sun Kim, MD, Samsung Medical Center, Seoul, South

Korea Matthias Matzko, MD, Amper Kliniken, Dachau, Germany Harsh Rastogi, MD, Indraprastha Apollo Hospital, New Delhi,

India


Hypothesis: Focused Ultrasound will provide a durable improvement for women with symptomatic uterine fibroids.

RELIEF Registry Hypothesis


Primary Objectives: Provide large scale evidence on the safety and long term efficacy of Focused Ultrasound for the indication of symptomatic uterine fibroids

Secondary Objectives: Assess the impact of the treatment on medical resource utilization and pregnancy outcomes

RELIEF Registry Objectives


Primary endpoints:• Treatment effectiveness using UFS-SSS• Need/reason for alternative treatments• Treatment safety using adverse events

Secondary endpoints:• Treatment satisfaction• Recovery using return to work and/or normal activities

Exploratory endpoints:• Medical resources utilization• Pregnancy outcomes• General health-related quality life

RELIEF Registry Outcomes of Interest


Target –1,000 women in two years, three years follow-up.

Approximately 30 sites in:• North America - U.S., Canada• Europe - Germany, United Kingdom• Asia - Korea, India, Israel

Each site will enroll approximately 50 consecutive patients who receive Focused Ultrasound

RELIEF Registry Registry Design


~30 Sites

Treatment form completed

Self-report1 month, 6 month,

1-2-3 year surveys

Complete study

Baseline:Demographics Gynecologic history Uterine, fibroid anatomyFuture fertilitySymptoms and QoL

Follow-up Measures:Additional treatmentsTreatment SatisfactionResource utilization Pregnancy outcomesAEsSymptoms and QoL

Treatment Information: Duration,Number of fibroids Treated fibroidsFibroid volume, NPVAEs

PROTOCOL

Treatment

Completebaseline Survey

1,000 planning to be treated

using focused ultrasound


Inclusion • Patient is

—Intended to be treated for symptomatic uterine fibroids by focused ultrasound (consistent with local labeling)

—Able to communicate over the phone/internet and can complete study questionnaires

—Willing to be followed for three years

Exclusion • Patient is

—Pregnant at time of treatment—Post-menopausal

RELIEF Registry Patient Population


Treatment guidelinesStructureBaseline dataShort-term resultsMid-term results Long-term resultsOther analyses TBD

RELIEF Registry Publications


Enrollment to begin second half this year

Sites to come onboard soon – potential US locations to include:

Bethesda, MDBoca Raton, FLBoston, MACharlottesville, VAChicago, ILColumbus, OH

Houston, TXNashville, TNRochester, MNSan Diego, CASan Francisco, CAStanford, CA

RELIEF Registry Status


REFERRING PATIENTS TO RELIEF

Every patient treated in the U.S. will be eligible for the registry

RELIEF will systematically collect data and provide evidence-based recommendations for patient selection and outcomes

www.fibroidrelief.org/registry© 2013 by Focused Ultrasound Foundation

introducing the relief registry dr. jaron rabinovici sheba medical center, israel

Documents