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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01998854
• Other study ID #: CL03537
• Status: Terminated
• Phase: N/A
• First received: November 25, 2013
• Last updated: March 9, 2015
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Gynesonics
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Uterine Fibroids
• Uterine Fibroma
• Uterine Neoplasms

Intervention

Device:
• VizAblate System
The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre	Paris
France	Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau	Tours	Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Gynesonics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage change in treated fibroid perfused volume		12 months	No
Secondary	Fibroid total volume reduction		12 months	No
Secondary	Incidence of Intrauterine adhesiogenesis	The cavity will be as classified per the European Society for Hysteroscopy (ESH)	7 weeks	No
Secondary	Procedure Safety	Frequency and type of adverse events occurring on the day of the procedure	Day of procedure	Yes
Secondary	Long-term safety	Frequency and type of adverse events occurring post treatment through 12 months	12 months	Yes
Secondary	Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire		12 months	No
Secondary	Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire		12 months	No
Secondary	Rate of surgical reintervention for menorrhagia		12 months	No