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

Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores

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.

Study Overview

• Status: Withdrawn
• Conditions: Leiomyoma; Uterine Fibroids; Menorrhagia
• Intervention / Treatment: Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2A8
      • Victoria General Hospital; Mature Women's Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
    • Toronto, Ontario, Canada, M6R 1B5
      • St. Joseph's Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)	Baseline, 3 mo, 6 mo, 9 mo, 12 mo

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of surgical reintervention	12 mo
Quality of Life questionnaires	Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Time required to return to normal daily activity	7-14 days
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

Collaborators and Investigators

• Sponsor: Gynesonics
• Investigators: Study Director: David Toub, M.D., Gynesonics

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: VizAblate; Uterine Fibroid RF Ablation; Intrauterine Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID Numbers: CL00635; HC-126128