The Focused Ultrasound Foundation, Royal Philips Electronics and InSightec Ltd today announced that they are collaborating with leading clinicians in the field and support the establishment of a multicenter registry to evaluate MR-guided focused ultrasound treatment for uterine fibroids (also known as uterine leiomyomas).
The international registry, titled RELIEF (REgistry for Leiomyoma: International Efficacy of Focused Ultrasound) will start in the second half of 2013. Over a three-year period, the registry will collect data from 1,000 women treated with focused ultrasound. The resulting database is intended to provide large scale evidence on safety, efficacy and long-term durability of this novel treatment for uterine fibroids to facilitate reimbursement and drive rapid physician acceptance. More than 30 leading treatment sites will participate in the studies. Furthermore, all active MR-guided focused ultrasound sites are welcome to participate.
The announcement was made at a symposium today on the Future of Fibroid Treatment hosted by the Focused Ultrasound Foundation's patient education program Fibroid Relief.
"MR-guided focused ultrasound is a new and completely non-invasive, uterine-preserving treatment alternative to hysterectomy," said initiator of the study and principal investigator Jaron Rabinovici, M.D., vice chairman of the department of obstetrics and gynecology, Sheba Medical Center, Israel. "It is our hope that the RELIEF registry will help to accelerate the adoption of this option by providing additional evidence to assure payers that the treatment is not only effective in the short-term, but also a long-term solution for women seeking relief from their fibroid symptoms."
Rabinovici continued: "Each year, there are thousands of women who could benefit from this low risk procedure, but who are currently forced to select a more invasive alternative out of concern that their insurer will not pay for the treatment. In today's healthcare environment, payers have higher thresholds for novel technologies which can severely limit widespread acceptance and access. RELIEF should provide the data that will help payers to make their decisions."
The primary and secondary outcomes of RELIEF will include quality of life, necessity of additional treatments, adverse events, satisfaction with the treatment, and time to return to work/normal activities. Additional measures will include medical resource utilization post-treatment, pregnancy, general health-related quality of life, and the association between fibroid treatment volume, age, baseline symptoms, fibroid characteristics and clinical outcome. The patients will be screened and expected to complete scheduled follow-up at intervals of 1 and 6 months and 1, 2, and 3 years after treatment. Registry data from key milestones and the final analysis will be submitted for publication.
The RELIEF registry Steering Committee oversees the design, monitoring and follow-up of the registry. Dr. Rabinovici leads the Steering Committee of global focused ultrasound experts that includes Anne Roberts, M.D. (University of California, San Diego); Elizabeth A. Stewart, M.D. (Mayo Clinic, Rochester, Minn.); Robert K. Zurawin, M.D. (Baylor College of Medicine, Houston); Elizabeth David, MD (Sunnybrook Health Sciences Centre, Toronto, Canada); Wladyslaw M. Gedroyc, M.D. (St. Mary's Hospital, London, UK); Young-Sun Kim, M.D. (Samsung Medical Center, Seoul, South Korea); Matthias Matzko, M.D. (Amper Kliniken, Dachau, Germany); and Harsh Rastogi, M.D. (Indraprastha Apollo Hospital, New Delhi, India).
The RELIEF registry will be conducted through Fibroid Relief, with regulatory oversight and operational management in collaboration with KAI Research, Inc.