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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768742
Recruitment Status : Withdrawn (study revised and reinitiated under another protocol)
First Posted : October 8, 2008
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Leiomyoma Uterine Fibroids Menorrhagia Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation
    VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

Primary Outcome Measures :
  1. Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ]

Secondary Outcome Measures :
  1. Rate of surgical reintervention [ Time Frame: 12 mo ]
  2. Quality of Life questionnaires [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ]
  3. Time required to return to normal daily activity [ Time Frame: 7-14 days ]
  4. Adverse events [ Time Frame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. ]
  5. Subject tolerance of procedure rated via analog visual scale [ Time Frame: Discharge ]
  6. Fibroid dimension and non-perfused volume [ Time Frame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo ]
  7. Pregnancy and pregnancy-related complications [ Time Frame: 3 mo, 6 mo, 9 mo, and 12 mo ]

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768742

Canada, Manitoba
Victoria General Hospital; Mature Women's Centre
Winnipeg, Manitoba, Canada, R3T 2A8
Canada, Ontario
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Study Director: David Toub, M.D. Gynesonics

Responsible Party: Gynesonics Identifier: NCT00768742     History of Changes
Other Study ID Numbers: CL00635
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Gynesonics:
Uterine Fibroid RF Ablation
Intrauterine Ultrasound

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes