Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

Terminated

• Conditions: Leiomyoma; Uterine Fibroma; Uterine Neoplasms; Menorrhagia; Uterine Fibroids
• Interventions: Device: VizAblate System

• Registration Number: NCT01998854
• Lead Sponsor: Gynesonics

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-02
• Primary Completion: 2014-06
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VizAblate treatment	VizAblate System	VizAblate System with subject serving as her own control

Primary Outcome Measures

Name	Time	Method
Mean percentage change in treated fibroid perfused volume	12 months

Secondary Outcome Measures

Name	Time	Method
Long-term safety	12 months	Frequency and type of adverse events occurring post treatment through 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
Fibroid total volume reduction	12 months
Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire	12 months
Rate of surgical reintervention for menorrhagia	12 months
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

Trial Locations

Locations (2)

Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau; 🇫🇷 Tours, Cedex, France

Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre; 🇫🇷 Paris, France