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

This study has been withdrawn prior to enrollment.
(study revised and reinitiated under another protocol)
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT00768742
First received: October 6, 2008
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention
Leiomyoma
Uterine Fibroids
Menorrhagia
Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gynesonics:

Primary Outcome Measures:
  • Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of surgical reintervention [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Quality of Life questionnaires [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ] [ Designated as safety issue: No ]
  • Time required to return to normal daily activity [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. ] [ Designated as safety issue: Yes ]
  • Subject tolerance of procedure rated via analog visual scale [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Fibroid dimension and non-perfused volume [ Time Frame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo ] [ Designated as safety issue: No ]
  • Pregnancy and pregnancy-related complications [ Time Frame: 3 mo, 6 mo, 9 mo, and 12 mo ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768742

Locations
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
Gynesonics
Investigators
Study Director: David Toub, M.D. Gynesonics
  More Information

No publications provided

Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT00768742     History of Changes
Other Study ID Numbers: CL00635, HC-126128
Study First Received: October 6, 2008
Last Updated: November 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by Gynesonics:
Uterine Fibroid RF Ablation
Intrauterine Ultrasound
VizAblate

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

ClinicalTrials.gov processed this record on November 19, 2014