RecruitingNot ApplicableNCT06312722

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

Sponsor

Urotronic Inc.

Enrollment

92 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia

Summary

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Optilume® BPH Catheter System for people with benign prostatic hyperplasia. The study is currently recruiting participants at 7 locations. People eligible for this study include men aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOptilume® BPH Catheter System

The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.