LeiomyomaFAST-EUNCT01226290
Fibroid Ablation Study
A study testing VizAblate System in people with Leiomyoma and Uterine Fibroids, run by Gynesonics at 10 sites in 3 countries.
Trial summary
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids. Read more about this study
- Who is it for?
- Ages 28 years and older, women only
- Conditions the study is for
- Leiomyoma, Uterine Fibroids, Menorrhagia
- What is being tested?
- VizAblate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2011to Mar 2014
- 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 28 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 28 years of age or older
- Regular, consistent menstrual cycles
- History of excessive bleeding
- One Menstrual Pictogram score ≥ 120 during a one-month screening period
- Baseline Uterine Fibroid Symptom \& Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
- Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc
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- At least one fibroid must indent the endometrium
- Subject is not at material risk for pregnancy.
- Subject is willing to maintain use or non-use of hormonal contraception
- Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents
Who cannot join
- Subserosal fibroids with bulk symptoms
- Presence of type 0 intracavitary fibroids
- Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
- Any fibroid that obstructs access of the VizAblate probe
- Postmenopausal by history
- Desire for current or future fertility
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- Hemoglobin < 6 g/dl
- Pregnancy
- Evidence of disorders of hemostasis
- Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM)
- Short-term use of hormonal medication for management of bleeding
- Evidence for current cervical dysplasia
- Endometrial hyperplasia
- Confirmed abdominal / pelvic malignancy within the previous five years
- Active pelvic infection
- Clinically significant adenomyosis
- Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months
- Current use of anticoagulant therapy
- Need for emergency surgery to treat fibroid symptoms
- Concomitant intrauterine polyps > 1.0 cm
- Contraindication to MRI
- Renal insufficiency
- Uncontrolled hypertension lasting 2 years or more
- One or more treatable fibroids that are calcified
- Chronic pelvic pain
- Presence of an extrauterine pelvic mass
- Presence of a tubal implant for sterilization
- Previous pelvic irradiation
- Endometrial cavity length < 4.5 cm
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United Kingdom5 sites
Birmingham Women's NHS Foundation Trust
Birmingham, West Midlands, B15 2TG
Bradford Teaching Hospitals NHS Trust
Bradford, West Yorkshire, BD9 6RJ
Princess Royal Hospital
Haywards Health, West Sussex, RH16 3EJ
University College Hospital
London, London, NW1 2BU
Royal London Hospital
Whitechapel, London, E1 1BB
Netherlands4 sites
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, 1007
Medisch Spectrum Twente
Enschede, 7513 ER
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3430
Máxima Medisch Centrum
Veldhoven, North Brabant, 5500
Mexico1 site
Universidad Autonoma de Nuevo Leon (UANL)
Monterrey, Nuevo León, 64460
About this study
Official title: Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Being tested
- VizAblate System
- 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 SystemDevice
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
| Study group | Role | What they receive |
|---|---|---|
| VizAblate treatment | Experimental | VizAblate System: subject acts as her own control Receives: Device: VizAblate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage change in target fibroid perfused volume
Measured: 3 months
Secondary outcomes (5)
Number of adverse events
Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
Measured: procedure through 12 mo
Percentage reduction in Menstrual Pictogram score
Measured: baseline through 12 months
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire
Measured: baseline through 12 months
Rate of surgical reintervention for menorrhagia
Measured: through 12 months
Return to normal daily activity
Measured: 2 weeks or until returned to normal activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Investigational device changes; adequate enrollment achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynesonics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Toub, MD, Study director, Gynesonics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226290
- Sponsor's protocol ID
- CL02413
- Acronym
- FAST-EU
- Status last verified
- Mar 2015
- First submitted
- 20 Oct 2010
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.
PubMed 33544889
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01226290
- Acronym / sponsor ID
- FAST-EU / CL02413
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Keywords
- uterine fibroid RF ablation, intrauterine ultrasound, VizAblate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational device changes; adequate enrollment achieved
- Enrolment
- 51 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Oct 2010 (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 establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VizAblate treatment | Experimental | Device: VizAblate SystemVizAblate System: subject acts as her own control |
Who may qualify
- Ages
- 28 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 28 years of age or older
- Regular, consistent menstrual cycles
- History of excessive bleeding
- One Menstrual Pictogram score ≥ 120 during a one-month screening period
- Baseline Uterine Fibroid Symptom \& Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
Key exclusion criteria (29 listed)
- Subserosal fibroids with bulk symptoms
- Presence of type 0 intracavitary fibroids
- Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
- Any fibroid that obstructs access of the VizAblate probe
- Postmenopausal by history
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 SystemVizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy. | Device | VizAblate treatment |
Primary outcome
Mean percentage change in target fibroid perfused volume
Time frame: 3 months
5 secondary outcomes
Number of adverse events
Time frame: procedure through 12 mo
Percentage reduction in Menstrual Pictogram score
Time frame: baseline through 12 months
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire
Time frame: baseline through 12 months
Rate of surgical reintervention for menorrhagia
Time frame: through 12 months
Return to normal daily activity
Time frame: 2 weeks or until returned to normal activity
Results and safety
The study was stopped early (reason given: Investigational device changes; adequate enrollment achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Derived from this study: PubMed 33544889Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.
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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, MD study director
Gynesonics
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VizAblate System in people with Leiomyoma and Uterine Fibroids, run by Gynesonics at 10 sites in 3 countries.
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 10 inclusion and 29 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: stopped early, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Netherlands, Mexico. 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 stopped early (reason given: Investigational device changes; adequate enrollment achieved). Results are not available in the source record.
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?
Mean percentage change in target fibroid perfused volume (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226290, which also lists 1 linked publication.
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 2 Apr 2015.