Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
- Conditions
- Uterine FibroidsMenorrhagiaLeiomyoma
- Registration Number
- NCT00768742
- Lead Sponsor
- Gynesonics
- Brief Summary
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Pre-menopausal
- Regular, consistent menstrual cycles
- Serum progesterone > 6 ng/ml (19 nmol/L)
- 2 months history of PBLAC score of 150-500
- Maximum of 4 type I, type II, or intramural fibroids
- Patient is at low risk for cervical cancer
- Hemoglobin > 6 g/dl
- Not at risk for pregnancy
- No desire for future fertility
- Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
- Willing to sign a consent form
- Subserosal fibroids.
- Any fibroid that obstructs access to the endometrial cavity
- FSH > 20 IU/L
- Pregnancy
- Evidence of disorders of hemostasis
- Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
- SERMS/SPRMS within the last 6 months
- Current use of any IUD or use of Mirena IUS within the last 3 months
- Gynecological malignancy or hyperplasia
- Known/suspected abdominal/pelvic cancer
- Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
- Adenomyosis
- Previous surgical or ablative treatment for fibroids or menorrhagia
- Previous uterine artery embolization or occlusion
- Patient on anti-coagulation therapy
- Needing emergency surgery to treat fibroid symptoms
- Concomitant intrauterine polyps.
- Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data
- Contraindication to MRI
- Allergy to contrast media
- Mild renal insufficiency or worse
- Known renal disease
- Uncontrolled hypertension lasting 2 years or more
- Diabetes
- Uterine size > 10 weeks or 10 cm from ectocervix to fundus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) Baseline, 3 mo, 6 mo, 9 mo, 12 mo
- Secondary Outcome Measures
Name Time Method Quality of Life questionnaires Baseline, 3 mo, 6 mo, 9 mo, 12 mo Rate of surgical reintervention 12 mo Adverse events At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. Subject tolerance of procedure rated via analog visual scale Discharge Fibroid dimension and non-perfused volume Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo Pregnancy and pregnancy-related complications 3 mo, 6 mo, 9 mo, and 12 mo Time required to return to normal daily activity 7-14 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (3)
Victoria General Hospital; Mature Women's Centre
🇨🇦Winnipeg, Manitoba, Canada
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
St. Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada
Victoria General Hospital; Mature Women's Centre🇨🇦Winnipeg, Manitoba, Canada