This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
University of California at San Diego
La Jolla, California, United States
Lahey Clinic
Burlington, Massachusetts, United States
KNI
Kalamazoo, Michigan, United States
Cornell Vascular
New York, New York, United States
Number of Adverse Events
The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Time frame: Within 1 month of treatment
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Toronto General Hospital
Toronto, Ontario, Canada