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Withdrawn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
|
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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 |
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Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ]
- 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 ]

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Ages Eligible for Study: | 25 Years and older (Adult, Senior) |
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.

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 ClinicalTrials.gov 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 |
Study Director: | David Toub, M.D. | Gynesonics |
Responsible Party: | Gynesonics |
ClinicalTrials.gov Identifier: | NCT00768742 History of Changes |
Other Study ID Numbers: |
CL00635 HC-126128 |
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 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 |