Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

Not Applicable

Withdrawn

• Conditions: Uterine Fibroids; Menorrhagia; Leiomyoma

• 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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-22
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

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