Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 65
Summary
- Conditions
- Benign Prostatic Hyperplasia
- Benign Prostatic Hypertrophy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation CatheterMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Only males
Description
A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects m...
A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first. Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System. Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.
Tracking Information
- NCT #
- NCT03423979
- Collaborators
- Not Provided
- Investigators
- Study Director: Jill Moland Urotronic Inc.
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