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

NCT06312722 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-01-14

No results posted yet for this study

Summary

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

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Optilume® 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.

Sponsors & Collaborators

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Kaplan, MD, FACS · Professor of Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2031-02-07
Completion
2031-02-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312722 on ClinicalTrials.gov