Leiomyoma, Menorrhagia, Uterine Fibroids, Uterine Fibroma, Uterine Neoplasms
Conditions
Keywords
Menorrhagia, Leiomyoma, Uterine Fibroids
Brief 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. 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.
Interventions
DEVICEVizAblate System
The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids
Sponsors
Gynesonics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
28 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in treated fibroid perfused volume | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intrauterine adhesiogenesis | 7 weeks | The cavity will be as classified per the European Society for Hysteroscopy (ESH) |
| Procedure Safety | Day of procedure | Frequency and type of adverse events occurring on the day of the procedure |
| Long-term safety | 12 months | Frequency and type of adverse events occurring post treatment through 12 months |
| Fibroid total volume reduction | 12 months | — |
| Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire | 12 months | — |
| Rate of surgical reintervention for menorrhagia | 12 months | — |
| Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire | 12 months | — |
Countries
France
Outcome results
None listed