MenorrhagiaNCT01998854
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
An observational study of Menorrhagia and Leiomyoma, run by Gynesonics at 2 sites in France.
Trial summary
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Read more about this study
- Who is it for?
- Ages 28 years and older, women only
- Conditions the study is for
- Menorrhagia, Leiomyoma, Uterine Fibroids
- What is being tested?
- VizAblate System
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2013to Jan 2015
- Phase
- Observational
- 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
Study population: Patients of specified clinical sites with complaint of symptomatic uterine fibroids.
Who may be able to join
- 28 years of age or older
- Indication for transcervical treatment of uterine fibroids associated with menorrhagia
- Willingness to participate in the study, to attend all follow-up visits and undergo all study assessments, and to sign the informed consent form
- Presence of submucosal and/or intramural fibroids
Who cannot join
- Pregnancy
- ≥40 years of age with desire for current or future fertility, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
- Non-sterilized patients < 40 years of age, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
- Active pelvic infection, known or suspected gynecologic malignancy or premalignant condition
- Presence of tubal implant for sterilization
- Previous pelvic irradiation
Show all 10Show fewer
- Endometrial cavity length, including endocervical canal, < 4.5 cm
- Any abnormality of the vagina or uterine cavity that, in the judgment of the investigator obstructs access of the VizAblate handpiece to the endometrial cavity
- Presence of cardiac pacemaker or other active implant
- Post-menopausal
Trial locations and contacts
2 sites in 1 country.
France2 sites
Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre
Paris, 75475
Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau
Tours, Cedex, 37044
About this study
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.
Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.
Read the detailed description
In this single-arm study, subjects who receive transcervical intrauterine-ultrasound guided RF ablation of symptomatic uterine fibroids with the VizAblate® System will be assessed with 3D pelvic sonography with contrast, hysteroscopy, and quality of life questionnaires.
Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.
- Conditions
- Menorrhagia, Leiomyoma, Uterine Fibroids, Uterine Fibroma, Uterine Neoplasms
- Being tested
- VizAblate System
- Keywords
- Menorrhagia, Leiomyoma, Uterine Fibroids
- Medical subject headings
- Menorrhagia, Leiomyoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VizAblate SystemDevice
The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids
| Study group | Role | What they receive |
|---|---|---|
| VizAblate treatment | VizAblate System with subject serving 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 treated fibroid perfused volume
Measured: 12 months
Secondary outcomes (7)
Fibroid total volume reduction
Measured: 12 months
Incidence of Intrauterine adhesiogenesis
The cavity will be as classified per the European Society for Hysteroscopy (ESH)
Measured: 7 weeks
Procedure Safety
Frequency and type of adverse events occurring on the day of the procedure
Measured: Day of procedure
Long-term safety
Frequency and type of adverse events occurring post treatment through 12 months
Measured: 12 months
Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire
Measured: 12 months
Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire
Measured: 12 months
Rate of surgical reintervention for menorrhagia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJan 2015
Why it stopped: Investigational device changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 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
- NCT01998854
- Sponsor's protocol ID
- CL03537
- Status last verified
- Mar 2015
- First submitted
- 25 Nov 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
- ClinicalTrials.gov ID
- NCT01998854
- Acronym / sponsor ID
- CL03537
- Conditions
- Menorrhagia, Leiomyoma, Uterine Fibroids, Uterine Fibroma, Uterine Neoplasms
- Keywords
- Menorrhagia, Leiomyoma, Uterine Fibroids
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigational device changes
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Dec 2013 (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.
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.
Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.
Detailed description
In this single-arm study, subjects who receive transcervical intrauterine-ultrasound guided RF ablation of symptomatic uterine fibroids with the VizAblate® System will be assessed with 3D pelvic sonography with contrast, hysteroscopy, and quality of life questionnaires.
Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VizAblate treatment | – | Device: VizAblate SystemVizAblate System with subject serving as her own control |
Who may qualify
- Ages
- 28 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of specified clinical sites with complaint of symptomatic uterine fibroids.
Key inclusion criteria (4 listed)
- 28 years of age or older
- Indication for transcervical treatment of uterine fibroids associated with menorrhagia
- Willingness to participate in the study, to attend all follow-up visits and undergo all study assessments, and to sign the informed consent form
- Presence of submucosal and/or intramural fibroids
Key exclusion criteria (10 listed)
- Pregnancy
- ≥40 years of age with desire for current or future fertility, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
- Non-sterilized patients < 40 years of age, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
- Active pelvic infection, known or suspected gynecologic malignancy or premalignant condition
- Presence of tubal implant for sterilization
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 SystemThe VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids | Device | VizAblate treatment |
Primary outcome
Mean percentage change in treated fibroid perfused volume
Time frame: 12 months
7 secondary outcomes
Fibroid total volume reduction
Time frame: 12 months
Incidence of Intrauterine adhesiogenesis
Time frame: 7 weeks
Procedure Safety
Time frame: Day of procedure
Long-term safety
Time frame: 12 months
Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire
Time frame: 12 months
Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire
Time frame: 12 months
Rate of surgical reintervention for menorrhagia
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Investigational device changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia and Leiomyoma, run by Gynesonics at 2 sites in France.
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 4 inclusion and 10 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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). 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 treated fibroid perfused volume (time frame: 12 months). 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 11 Mar 2015.