Women Needed for New Uterine Fibroid Study
A United States FDA Approved study that is aimed to validate a newer version of the only commercially available MRI guided focused ultrasound system , ExAblate, for treating uterine fibroids has begun. ExAblate MR-guided focused ultrasound is proved to be a real option for women who are seeking relief from uterine fibroid symptoms without having to undergo hysterectomy or other surgical procedures.
Women who have been diagnosed with symptomatic uterine fibroids and who are a good match for the study may be eligible to participate.
This study is recruiting patients - Call Lisa G. Peterson, RN 507-266-4813 email@example.com
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.
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.
This United States study tests the newer version of the commercially available ExAblate MRI guided focused ultrasound system for treating uterine fibroids. Published literature on the ExAblate MR guided focused ultrasound provides a wealth of significant clinical evidence of treated patient relief from uterine fibroid symptoms. Hysterectomy is currently the most common treatment for uterine fibroids, and it involves a long recovery time with many days lost from work and normal daily activities, not to mention the clinical impact on a women’s overall quality of life. The ExAblate Uterine Fibroid V2 is manufactured by InSightec.
What is the Objective of the Study?
Although, this recent version of the commercially available ExAblate has been approved for use in Europe and Israel since 2010, this study is conducted to gain regulatory approval to add the new version of the ExAblate system for commercialization for the treatment of symptomatic fibroids in the United States. The study aim is to validate the new features of this new ExAblate version.
What is Focused Ultrasound?
Focused ultrasound therapy uses magnetic resonance imaging (MRI) to guide the application of focused, high-intensity ultrasound waves through the skin down to the target tissue. The high-intensity sound waves are focused on the individual fibroids much like using a magnifying glass to focus the sun’s rays – only the focal point becomes hot enough to destroy the unwanted or problematic tissue. The MRI gives the treating physician a three-dimensional view of the uterus and fibroids and provides real-time feedback about the temperature and tissue changes that occur as each fibroid is ablated. Requiring no incision in an outpatient setting and allowing a rapid return to family or work, ExAblate MR-guided focused ultrasound offers women with symptomatic uterine fibroids a treatment option worth considering. InSightec’ s, ExAblate MR guided focused ultrasound has been approved by the FDA in the United States since 2004, and it has been used worldwide to treat more than 9,000 women. This clinical trial is testing ExAblate UF V2, the latest version of focused ultrasound system manufactured by InSightec and used exclusively with GE Healthcare MRI’s. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.
Where is the Study Taking Place?
|United States, California|
|Stanford University Medical Center||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Fizaa Ahmed 650-725-6409 firstname.lastname@example.org|
|Sub-Investigator: Pejman Ghanouni, M.D.|
United States, Massachusetts
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Louise Greenberg 617-732-5441 LGREENBERG@PARTNERS.ORG|
|Principal Investigator: Serene Srouji, M.D.|
United States, Virginia
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Brigitte Kelly 434-243-0315 BJK3C@hscmail.mcc.virginia.edu|
|Principal Investigator: Alan Matsumoto, MD|
Please consult ClinicalTrials.gov for the full list of centers: http://www.clinicaltrials.gov/ct2/show/NCT01285960?term=ExAblate+2100+UF&rank=2
Who is Eligible for the Study?
To be eligible for this FDA - approved study, patients must be women aged 18 or older who have been diagnosed with symptomatic uterine fibroids. Participants in the study must be pre or peri-menopausal (within 12 months of last menstrual period) and have a uterine size that is less than 24 weeks of a typical pregnancy. Women cannot participate if they have an active pelvic inflammatory disease or local or systemic infections. Women who participate in the study must be willing and able to undergo magnetic resonance imaging (MRI) and able and willing to attend all study visits. Women should have completed child bearing.
Women who are interested in participating should contact the coordinator at the nearest site to determine if they are a potential candidate for this study.
What Can Participants Expect?
If accepted to participate in the study, women will receive the MR guided focused ultrasound treatment. Participants will be followed up at 30 days and will be expected to complete study questionnaires and other requirements during the duration of the study.
Where Can I Find Additional Information?
More information about this study can be found at www.clinicaltrials.gov. A list of currently enrolling sites can be found on http://us.insightec.com/ under Clinical Trials. Contact the study coordinator at any of the enrolling sites to determine whether you might be a match for this particular study and to ask questions specific to your interest in and ability to participate.
About InSightec and ExAblate
InSightec is the pioneer and Worldwide leader for MR-guided Focused Ultrasound (MRgFUS) therapies, which are at the forefront of a shift towards non-invasive surgery. InSightec’ s ExAblate system is currently operating in sites across the globe, with clinical evidence documented in many peer-reviewed publications and textbooks. Thousands of patients have already benefitted from ExAblate’ s non-invasive MRgFUS treatments, while clinical tests for new applications are now underway.
ExAblate has been awarded many prizes for innovation and its potential to help mankind, including the Wall Street Journal Technology Award and the European Union’s IST Grand Prize. Business Week called it “one of 25 ideas for a changing world” and Time Magazine recently included it among the 50 best innovations.
* InSightec neither approves nor endorses this content