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Sponsored by: |
InSightec |
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Information provided by: | InSightec |
ClinicalTrials.gov Identifier: | NCT00131365 |
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: '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 |
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Leiomyoma |
Device: ExAblate 2000 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids |
Estimated Enrollment: | 20 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Background
General:
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. In general, these symptoms can be classified into two categories:
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.
ExAblate Device:
The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004.
Prior Studies:
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols.
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | UF014 - 4.1/3T |
Study First Received: | August 17, 2005 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00131365 |
Health Authority: | United States: Food and Drug Administration |
fibroids Uterine Fibroids ExAblate MrgFUS |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |