Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
InSightec |
---|---|
Information provided by: | InSightec |
ClinicalTrials.gov Identifier: | NCT00295217 |
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.
Condition | Intervention | Phase |
---|---|---|
Uterine Fibroids Uterine Leiomyomas |
Device: ExAblate 2000 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California at San Diego | |
LaJolla, California, United States, 92037 | |
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 | |
United States, Michigan | |
KNI | |
Kalamazoo, Michigan, United States, 49048 | |
United States, New York | |
Cornell Vascular | |
New York, New York, United States, 10022 |
Principal Investigator: | George Holland, M.D. | Lahey Clinic |
Principal Investigator: | Mark Shaman, M.D. | KNI |
Principal Investigator: | Robert Min, M.D. | Cornell |
Principal Investigator: | Anne Roberts, M.D. | University of California, San Diego |
Study ID Numbers: | UF017, Continued Access |
Study First Received: | February 21, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00295217 |
Health Authority: | United States: Food and Drug Administration |
Fibroids Uterine Leiomyomas ExAblate MrgFUS |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |