A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These
benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR
imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They
occur in 20-25% of women of reproductive age and can cause a variety of problems generally
described as either bleeding or mass effects from the fibroid. InSightec has developed an
Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue
ablation has been added to the already FDA approved ExAblate system. The goal of this ES
technique is to provide an additional treatment tool that will enhance the treatment effect
without additional risks while preserving ALL clinical features of the current commercially
approved version.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Within 1 month of treatment
No
Anne Roberts, M.D.
Principal Investigator
University of California, San Diego
United States: Food and Drug Administration
UF018
NCT00365989
October 2006
August 2008
Name | Location |
---|---|
University of California at San Diego | La Jolla, California 92093 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Cornell Vascular | New York, New York 10022 |
KNI | Kalamazoo, Michigan 49048 |