Cystoscopic Ablation Via RF Energy Clinical Trial
Phase 1
Terminated
- Conditions
- Overactive Bladder
- Interventions
- Device: Amphora OAB Device
- Registration Number
- NCT02398578
- Lead Sponsor
- Amphora Medical, Inc.
- Brief Summary
Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder.
- Detailed Description
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amphora OAB Device Amphora OAB Device Specialized cystoscope that facilitates visualization and radiofrequency (RF) therapy for the treatment of OAB.
- Primary Outcome Measures
Name Time Method Device-related complications through 24 month follow-up 24 month
- Secondary Outcome Measures
Name Time Method Procedural Success During the study procedure Change from Baseline of Quality of Life Scores 4 weeks, 12 weeks, 6, 12, 18, and 24 months Device Technical Success During the study procedure
Trial Locations
- Locations (4)
University of Antwerp
🇧🇪Antwerp, Belgium
University of Calgary
🇨🇦Calgary, Alberta, Canada
University Hospital Ghent
🇧🇪Ghent, Belgium
University of Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada