Feature | May 08, 2013

Launch of Multicenter RELIEF Registry to Collect Data on MR-Guided Focused Ultrasound Treatment for Uterine Fibroids

Focused Ultrasound Foundation, Philips and InSightec collaborate with leading clinicians and support the establishment of the international multicenter RELIEF registry

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. 

For more information: www.fusfoundation.org, www.philips.com/newscenter, us.insightec.com

 

Related Content

Russian Team Developing New Technology to Significantly Reduce MRI Research Costs
News | Magnetic Resonance Imaging (MRI) | January 16, 2018
January 16, 2018 — Researchers from the NUST MISIS Engineering Center for Industrial Technologies in Russia have deve
Transpara Deep Learning Software Matches Experienced Radiologists in Mammogram Reading
News | Computer-Aided Detection Software | January 12, 2018
Deep learning and artificial intelligence improves the efficiency and accuracy of reading mammograms, according to...
Smartphone Addiction Creates Imbalance in Brain
News | Mobile Devices | January 11, 2018
Researchers have found an imbalance in the brain chemistry of young people addicted to smartphones and the internet,...
Fat Distribution in Women and Men Provides Clues to Heart Attack Risk
News | Women's Health | January 11, 2018
January 11, 2018 – It’s not the amount of fat in your body but where it is stored that may increase your risk for hea
Emergency Radiologists See Inner Toll of Opioid Use Disorders

Rates of Imaging Positivity for IV-SUDs Complications. Image courtesy of Efren J. Flores, M.D.

News | Clinical Study | January 11, 2018
January 11, 2018 – Emergency radiologists are seeing a high prevalence of patients with complications related to opio
Minimally Invasive Treatment Provides Relief from Back Pain

Lumbar spine MRI showing disc herniation and nerve root at baseline and one month after treatment

News | Interventional Radiology | January 11, 2018
The majority of patients were pain free after receiving a new image-guided pulsed radiofrequency treatment for low back...
Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
CT Shows Enlarged Aortas in Former Pro Football Players

3-D rendering from a cardiac CT dataset demonstrating mild dilation of the ascending aorta.

News | Computed Tomography (CT) | January 11, 2018
Former National Football League (NFL) players are more likely to have enlarged aortas, a condition that may put them at...

Size comparison between 3-D printed prosthesis implant and a penny.

News | 3-D Printing | January 11, 2018
January 11, 2018 — Researchers using...
RSNA 2017 technical exhibits, expo floor, showing new radiology technology advances.
Feature | RSNA 2017 | January 11, 2018
January 11, 2018 — Here is a list of some of the key clinical study presentations, articles on trends and videos from
Overlay Init