Status:
WITHDRAWN
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
Lead Sponsor:
Gynesonics
Conditions:
Leiomyoma
Uterine Fibroids
Eligibility:
FEMALE
25+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00768742
Start Date
September 1 2008
End Date
November 1 2010
Last Update
November 25 2013
Active Locations (3)
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1
Victoria General Hospital; Mature Women's Centre
Winnipeg, Manitoba, Canada, R3T 2A8
2
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
3
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5