An observational study in Menorrhagia, Leiomyoma and Uterine Fibroids, sponsored by Gynesonics. Terminated at 2 sites in France. Open to female participants aged 28 Years and older. Per ClinicalTrials.gov, last updated 2015-03-11.
Sponsored by Gynesonics (part of Hologic, Inc.) · Observational
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.
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.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
This study's enrollment of 4 is below the median of 210 across 47 observational studies indexed under Menorrhagia.
Browse Menorrhagia studies →Gynesonics is the lead sponsor of 7 studies on the registry; none are open to participants now.
First submitted before Gynesonics became part of Hologic, Inc..
Counted across the registry records on this site, refreshed daily.
Patients of specified clinical sites with complaint of symptomatic uterine fibroids.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VizAblate System with subject serving as her own control
Device: VizAblate System
The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids
Mean percentage change in treated fibroid perfused volume
Time frame: 12 months
Fibroid total volume reduction
Time frame: 12 months
Incidence of Intrauterine adhesiogenesis
The cavity will be as classified per the European Society for Hysteroscopy (ESH)
Time frame: 7 weeks
Procedure Safety
Frequency and type of adverse events occurring on the day of the procedure
Time frame: Day of procedure
Long-term safety
Frequency and type of adverse events occurring post treatment through 12 months
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
The record gives a start of Feb 2013, a primary completion of Jun 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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