Clinical trial NCT01998854: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Official title: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Menorrhagia
Leiomyoma
Uterine Fibroids
Uterine Fibroma
Uterine Neoplasms
Keywords: Menorrhagia
Leiomyoma
Uterine Fibroids
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of specified clinical sites with complaint of symptomatic uterine fibroids.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean percentage change in treated fibroid perfused volume
timeFrame: 12 months
Secondary outcomes:
measure: Fibroid total volume reduction
timeFrame: 12 months
measure: Incidence of Intrauterine adhesiogenesis
timeFrame: 7 weeks
measure: Procedure Safety
timeFrame: Day of procedure
measure: Long-term safety
timeFrame: 12 months
measure: Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire
timeFrame: 12 months
measure: Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire
timeFrame: 12 months
measure: Rate of surgical reintervention for menorrhagia
timeFrame: 12 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau
state: Cedex
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre
Study officials:
affiliation: Gynesonics
name: David Toub, MD
role: STUDY_DIRECTOR
References: