Back to resultsSafety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study (FAST)
Primary Purpose
Leiomyoma, Uterine Fibroids, Menorrhagia
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VizAblate Intrauterine Ultrasound-Guided RF Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate
Eligibility 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.
Sites / Locations
- Victoria General Hospital; Mature Women's Centre
- Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
- St. Joseph's Health Centre
Outcomes
Primary Outcome Measures
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
Secondary Outcome Measures
Rate of surgical reintervention
Quality of Life questionnaires
Time required to return to normal daily activity
Adverse events
Subject tolerance of procedure rated via analog visual scale
Fibroid dimension and non-perfused volume
Pregnancy and pregnancy-related complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00768742
Brief Title
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
Acronym
FAST
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
study revised and reinitiated under another protocol
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynesonics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine Fibroids, Menorrhagia
Keywords
Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
VizAblate Intrauterine Ultrasound-Guided RF Ablation
Intervention Description
VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Rate of surgical reintervention
Time Frame
12 mo
Title
Quality of Life questionnaires
Time Frame
Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Title
Time required to return to normal daily activity
Time Frame
7-14 days
Title
Adverse events
Time Frame
At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.
Title
Subject tolerance of procedure rated via analog visual scale
Time Frame
Discharge
Title
Fibroid dimension and non-perfused volume
Time Frame
Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo
Title
Pregnancy and pregnancy-related complications
Time Frame
3 mo, 6 mo, 9 mo, and 12 mo
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Toub, M.D.
Organizational Affiliation
Gynesonics
Official's Role
Study Director
Facility Information:
Facility Name
Victoria General Hospital; Mature Women's Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2A8
Country
Canada
Facility Name
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
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