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Brief Title: MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Official Title: A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Study ID: NCT00365989
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
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
Toronto General Hospital, Toronto, Ontario, Canada
Name: Anne Roberts, M.D.
Affiliation: University of California, San Diego
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Shaman, M.D.
Affiliation: KNI
Role: PRINCIPAL_INVESTIGATOR
Name: Robert Min, M.D.
Affiliation: Cornell
Role: PRINCIPAL_INVESTIGATOR
Name: David Gianfelice, M.D.
Affiliation: Toronto General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: George Holland, M.D.
Affiliation: Lahey Clinic
Role: PRINCIPAL_INVESTIGATOR