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This study has been withdrawn prior to enrollment.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:
Gynesonics
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT00768742
First received: October 6, 2008
Last updated: November 22, 2013
Last verified: November 2013
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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 (Adult, Senior) |
| 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
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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
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
| 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 Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Pathologic Processes |
ClinicalTrials.gov processed this record on September 28, 2016