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

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Neoplasms; Leiomyoma; Uterine Fibroids; Menorrhagia; Uterine Fibroma
• Intervention / Treatment: Device: VizAblate System

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75475
    • Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre
  • Cedex
    • Tours, Cedex, France, 37044
      • Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients of specified clinical sites with complaint of symptomatic uterine fibroids.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VizAblate treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean percentage change in treated fibroid perfused volume	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibroid total volume reduction		12 months
Incidence of Intrauterine adhesiogenesis	The cavity will be as classified per the European Society for Hysteroscopy (ESH)	7 weeks
Procedure Safety	Frequency and type of adverse events occurring on the day of the procedure	Day of procedure
Long-term safety	Frequency and type of adverse events occurring post treatment through 12 months	12 months
Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire		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

Collaborators and Investigators

• Sponsor: Gynesonics

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (ESTIMATE): December 2, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Uterine Fibroids; Menorrhagia; Leiomyoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Neoplasms, Fibrous Tissue; Leiomyoma; Myofibroma; Uterine Neoplasms; Fibroma; Menorrhagia
• Other Study ID Numbers: CL03537