At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Optilume™ BPH Prostatic DCB Dilation Catheter and Paclitaxel for Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy. Completed, enrolled 80 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).
paclitaxel will release to adjacent tissue after the balloon inflated in the urethra