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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Withdrawn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

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WITHDRAWN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
NameTimeMethod
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Secondary Outcome Measures
NameTimeMethod
Quality of Life questionnairesBaseline, 3 mo, 6 mo, 9 mo, 12 mo
Rate of surgical reintervention12 mo
Adverse eventsAt time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.
Subject tolerance of procedure rated via analog visual scaleDischarge
Fibroid dimension and non-perfused volumeBaseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo
Pregnancy and pregnancy-related complications3 mo, 6 mo, 9 mo, and 12 mo
Time required to return to normal daily activity7-14 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

Victoria General Hospital; Mature Women's Centre
🇨🇦Winnipeg, Manitoba, Canada

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