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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01998854
Other study ID # CL03537
Secondary ID
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


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
See also
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Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
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Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A