MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids|
- Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement. [ Time Frame: Within 1 month of Treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.
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:
- heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
- pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166270
|United States, California|
|Los Angeles, California, United States, 90025|
|United States, Florida|
|Boca Raton, Florida, United States, 33431|
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Burlington, Massachusetts, United States, 01805|
|United States, New Jersey|
|Voorhees, New Jersey, United States, 08043|
|United States, Texas|
|North Texas Uterine Fibroid Institute|
|Plano, Texas, United States, 75093|
|Principal Investigator:||Phyllis Gee, M.D.||North Texas UFI|
|Principal Investigator:||Paul Curtis, M.D.||Virtua|
|Principal Investigator:||George Holland, M.D.||Lahey Clinic|
|Principal Investigator:||Dennis Sarti, M.D.||Radnet Management|
|Principal Investigator:||Fred Steinberg, M.D.||Univeristy MRI|
|Principal Investigator:||Elizabeth Stewart, M.D.||Brigham and Women's Hospital|