Enhanced Sonications Study
An FDA-approved clinical trial is being conducted in the United States to collect additional data on ExAblate and the enhanced sonication technique, when treating up to 100% individual fibroid volume. This study is being conducted according to the current US commercial labeling and treatment guidelines.
If you would like to participate in the trial please contact one of the following treatment locations:
United States, Virginia
University of Virginia Health System - Recruiting Now!
Charlottesville, VA 22908
Contact: Sandra Burks, Telephone: 434-243-0315
Email: sgb2c@virginia.edu
Principal Investigator: Alan Matsumoto, MD
United States, California
UCLA - Recruiting Now!
Los Angeles, California 90095
Contact: Polly Kay
Phone: 310-794-0376
Email: pkay@mednet.ucla.edu
Principal Investigator: Steve Raman , MD
United States, California
University of California San Diego - Recruiting Now!
UCSD Department of Radiology
Contact: Lillian Pacheco, Phone: 619-543-5830
Email: lpacheco@ucsd.edu
Principal Investigator: Anne Roberts , MD
United States, Texas
The Methodist Hospital Research Institute - Recruiting Now!
Contact: Melissa Whipple; phone: 713-441-3247;
Email: mlambeth@tmhs.org
Principal Investigator: King Li, MD
United States, Georgia
Atlanta Interventional Institute - Not yet recruiting
Smyrna, Georgia, United States, 30080
Contact: Margie Mancao 770-801-4694 Margie.mancao@ahss.org
Principal Investigator: John Lipman, MD
United States, North Carolina
Duke University - Recruiting Now!
Durham, North Carolina, United States, 27705
Contact: Kristen Lynam, BA, RN 919-668-7467 kristen.lynam@duke.edu
Principal Investigator: Haywood Brown, MD
University of California San Francisco - Recruiting Now!
San Francisco, CA 94107
Contact: Martha French
Phone: 415-353-4616
e-mail: Martha.french@ucsf.edu
Principal investigator: Fergus Coakley, MD
Click here for additional information on eligibility requirements:
Study Comparing MRgFUS to UAE
Mayo Clinic and Duke University are conducting the first study to compare uterine artery embolization (UAE) and MR-guided focused ultrasound (MRgFUS) for the treatment of uterine fibroids.
The study, called Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), will randomly assign women to be treated with either UAE or MRgFUS. The study will follow patients for three years to assess how effective the treatments are in symptom relief, absence of side effects, impact on quality of life, need for additional treatment, and even the costs associated with each approach.
The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.
http://clinicaltrials.gov/ct2/show/NCT00995878?term=Magnetic+Resonance-guided+Focused+Ultrasound&rank=7
The study is now enrolling 220 women who can be treated at Mayo Clinic in Rochester, Minnesota or Duke University in Durham, North Carolina.
To find out more about the study and whether you are eligible to participate, please click here.
PROMISe
This study is currently recruiting participants.
Verified on June 2011 by University of California, San Francisco
This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
Here is the link:
http://clinicaltrials.gov/ct2/show/NCT01377519?term=Magnetic+Resonance-guided+Focused+Ultrasound&rank=2
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
The study is taking place at the University of California, San Francisco.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377519
For more information on this study and to check your eligibility, pleases contact:
University of California, San Francisco
San Francisco, California, United States, 94115
Contact: Shirley Wong 415-502-4082
Principal Investigator: Vanessa Jacoby, MD
Sub-Investigator: Fergus Coakley, MD
A Clinical Safety Study with ExAblate 2100 Uterine Fibroids V.2 System
A clinical study to evaluate safety of the ExAblate 2100 uterine fibroids V2 system in the treatment of symptomatic uterine fibroids, is taking place at the following treatment locations (this study is taking place outside of the USA).
Radiopharmaceutiques Hôpital Bretonneau, Tours, France; Sheba Medical Center, Ramat Gan, Israel; St. Mary’s Hospital, London, UK; Research Centre of Obstetric/ Gynaecology & Perinatology, Moscow, Russian Federation.
A Study Comparing MRgFUS with Myomectomy
This study is taking place outside of the USA.
An ongoing study to evaluate the safety and effectiveness of MRgFUS compared with myomectomy for the treatment of uterine fibroids is taking place at St. Mary's Hospital, London, UK.
