NCT01998854

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Gynesonics · Industry
• Sex: Female
• Age: 28 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	VizAblate System	The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-06-01
• Completion: 2015-01-01
• First posted: 2013-12-02
• Last updated: 2015-03-11

Locations

2 sites across 1 country: France