Clinical Trials
A Phase IV Clinical Study to Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
IRB-HSR# 15182
Service:
Women's Health
|
Category: Women's Health
Adult Enrollment: Yes
|
Minor Enrollment: No
Primary Investigator: Alan Matsumoto, MD
Contact Information
Contact: Study Nurse Coordinators at the Surgical Therapeutic Advancement Center
Phone: 434.243.0315
E-mail: uvastac@virginia.edu
Clinical Trial Description
Uterine fibroids
are common, non-cancerous tumors of the uterus. Uterine fibroids may
cause problems such as heavy menstrual periods, pain or pressure in the
pelvic area or frequent urination.
UVa Health System, Department of Radiology seeks adult women with
uterine fibroids who are seeking treatment with MR-Guided Focused
Ultrasound (The ExAblate device) for participation in a clinical trial.
The purpose of this study is to collect additional data to further
evaluate the safe use of the MR-Guided Focused Ultrasound with the
ExAblate device using enhanced sonications for the treatment of uterine
fibroids.
The study would involve at least 4 visits to UVA: A
screening/consultation visit, up to 2 treatment visits with the ExAblate
device, and follow up clinic visits at 1 week and 1 month after the
last treatment.
Financial Information
If you participate in this study, and meet eligibility requirements, the
following tests and procedures will be provided at no cost to you:
- ExAblate treatment procedure(s)
- Urine pregnancy tests and kidney blood test required by the study
- MRI at baseline (if you have not already had one prior to enrolling in
this study)
- Follow up clinic visit at 1 week after your last ExAblate treatment
- Quality of life questionnaires You will be responsible for travel costs associated with your visits to UVA as well as any additional charges associated with treatment for your condition that are not associated with your participation in this study.
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