ExAblate for the treatment of uterine fibroids
An FDA-approved clinical trial is being conducted in the United States for the treatment of uterine fibroids. The treatment is being done on the ExAblate system with the enhanced sonication technique, when treating up to 100% individual fibroid volume. The enhanced sonication is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.
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.
Participate in the clinical trial by contacting 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
Principal Investigator: Alan Matsumoto, MD
United States, California
UCLA - Recruiting Now!
Los Angeles, California 90095
Contact: Polly Kay
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
Principal Investigator: Anne Roberts , MD
United States, Texas
The Methodist Hospital Research Institute - Recruiting Now!
Contact: Melissa Whipple; phone: 713-441-3247;
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.firstname.lastname@example.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 email@example.com
Principal Investigator: Haywood Brown, MD
University of California San Francisco - Recruiting Now!
San Francisco, CA 94107
Contact: Martha French
Principal investigator: Fergus Coakley, MD
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