MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.
George Holland, M.D.
Principal Investigator
Lahey Clinic
United States: Food and Drug Administration
UF017
NCT00295217
February 2006
October 2006
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 |