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

• Sponsor: Gynesonics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01998854
• Collaborator: (none)
• Enrollment: 4
• Locations: 2
• Duration (Months): 23
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia; Leiomyoma; Uterine Fibroids; Uterine Fibroma; Uterine Neoplasms	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 Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Mean percentage change in treated fibroid perfused volume [12 months]

Secondary Outcome Measures

1. Fibroid total volume reduction [12 months]

2. Incidence of Intrauterine adhesiogenesis [7 weeks]

   The cavity will be as classified per the European Society for Hysteroscopy (ESH)

3. Procedure Safety [Day of procedure]

   Frequency and type of adverse events occurring on the day of the procedure

4. Long-term safety [12 months]

   Frequency and type of adverse events occurring post treatment through 12 months

5. Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire [12 months]

6. Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire [12 months]

7. Rate of surgical reintervention for menorrhagia [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau	Tours	Cedex	France	37044
2	Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre	Paris		France	75475

Sponsors and Collaborators

• Gynesonics

Investigators

• Study Director: David Toub, MD, Gynesonics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynesonics
• ClinicalTrials.gov Identifier: NCT01998854
• Other Study ID Numbers: CL03537
• First Posted: Dec 2, 2013
• Last Update Posted: Mar 11, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Gynesonics: Menorrhagia; Leiomyoma; Uterine Fibroids
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Uterine Neoplasms; Fibroma; Menorrhagia

Study Results

No Results Posted as of Mar 11, 2015