NCT03423979

Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Urotronic Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Detailed 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 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.

Conditions

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DEVICE	Optilume™ BPH Prostatic DCB Dilation Catheter	BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).
DRUG	Paclitaxel	paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Timeline

• Start date: 2017-12-19
• Primary completion: 2019-06-04
• Completion: 2024-05-25
• First posted: 2018-02-06
• Last updated: 2025-11-26
• Results posted: 2023-07-03

Locations

5 sites across 2 countries: Dominican Republic, Panama

Regulatory

• FDA-regulated device study