Spots Global Cancer Trial Database for Safety Study of ExAblate for the Treatment of Uterine Fibroids
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Trial Identification
Brief Title: Safety Study of ExAblate for the Treatment of Uterine Fibroids
Official Title: A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Study ID: NCT01142791
Conditions
Interventions
Study Description
Brief Summary: The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids. The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
UCSD Department of Radiology, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
University Image Guided Therapy, Boca Raton, Florida, United States
Borgess Research Institute, Kalamazoo, Michigan, United States
Duke University, Durham, North Carolina, United States
The Methodist Hospital Research Institute, Houston, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Contact Details
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