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

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ClinicalTrials.gov Identifier: NCT00768742
Recruitment Status : Withdrawn (study revised and reinitiated under another protocol)
First Posted : October 8, 2008
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gynesonics

October 6, 2008
October 8, 2008
November 25, 2013
September 2008
November 2010   (Final data collection date for primary outcome measure)
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ]
Same as current
Complete list of historical versions of study NCT00768742 on ClinicalTrials.gov Archive Site
  • Rate of surgical reintervention [ Time Frame: 12 mo ]
  • Quality of Life questionnaires [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ]
  • Time required to return to normal daily activity [ Time Frame: 7-14 days ]
  • Adverse events [ Time Frame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. ]
  • Subject tolerance of procedure rated via analog visual scale [ Time Frame: Discharge ]
  • Fibroid dimension and non-perfused volume [ Time Frame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo ]
  • Pregnancy and pregnancy-related complications [ Time Frame: 3 mo, 6 mo, 9 mo, and 12 mo ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
40
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00768742
CL00635
HC-126128
No
Not Provided
Not Provided
Gynesonics
Gynesonics
Not Provided
Study Director: David Toub, M.D. Gynesonics
Gynesonics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP