LeiomyomaFASTNCT00768742
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
A study testing VizAblate Intrauterine Ultrasound-Guided RF Ablation in people with Leiomyoma and Uterine Fibroids, run by Gynesonics at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Leiomyoma, Uterine Fibroids, Menorrhagia
- What is being tested?
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
Victoria General Hospital; Mature Women's Centre
Winnipeg, Manitoba, R3T 2A8
About this study
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
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.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Being tested
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Keywords
- Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VizAblate Intrauterine Ultrasound-Guided RF AblationDevice
VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
Measured: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Secondary outcomes (7)
Rate of surgical reintervention
Measured: 12 mo
Quality of Life questionnaires
Measured: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Time required to return to normal daily activity
Measured: 7-14 days
Adverse events
Measured: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.
Subject tolerance of procedure rated via analog visual scale
Measured: Discharge
Fibroid dimension and non-perfused volume
Measured: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo
Pregnancy and pregnancy-related complications
Measured: 3 mo, 6 mo, 9 mo, and 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: study revised and reinitiated under another protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynesonics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Toub, M.D., Study director, Gynesonics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768742
- Sponsor's protocol ID
- CL00635
- Other IDs
- HC-126128
- Acronym
- FAST
- Status last verified
- Nov 2013
- First submitted
- 6 Oct 2008
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00768742
- Acronym / sponsor ID
- FAST / CL00635
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Keywords
- Uterine Fibroid RF Ablation, Intrauterine Ultrasound, VizAblate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study revised and reinitiated under another protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- Subserosal fibroids.
- Any fibroid that obstructs access to the endometrial cavity
- FSH > 20 IU/L
- Pregnancy
- Evidence of disorders of hemostasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VizAblate Intrauterine Ultrasound-Guided RF AblationVizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy. | Device | – |
Primary outcome
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
Time frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Toub, M.D. study director
Gynesonics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VizAblate Intrauterine Ultrasound-Guided RF Ablation in people with Leiomyoma and Uterine Fibroids, run by Gynesonics at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.