Actively Recruiting

MALE
NCT06560476

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Led by Urotronic Inc. · Updated on 2026-03-27

500

Participants Needed

9

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

CONDITIONS

Official Title

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Not Eligible

You will not qualify if you...

  • Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
  • Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
  • Confirmed or suspected malignancy of prostate or bladder
  • Active urinary tract infection (UTI)
  • Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Golden State Urology

Sacramento, California, United States, 95823

Withdrawn

2

Florida Urology Partners

Tampa, Florida, United States, 33615

Actively Recruiting

3

Kearney Urology Center

Kearney, Nebraska, United States, 68847

Actively Recruiting

4

The Urology Center, P.C.

Omaha, Nebraska, United States, 68144

Completed

5

Sheldon Freedman, Ltd

Las Vegas, Nevada, United States, 89144

Actively Recruiting

6

Northwell Health - Smith Institute of Urology

Syosset, New York, United States, 11791

Actively Recruiting

7

Good Samaritan Hospital

Corvallis, Oregon, United States, 97330

Completed

8

Midtown Urology

Austin, Texas, United States, 78705

Actively Recruiting

9

Potomac Urology

Woodridge, Virginia, United States, 22191

Completed

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Research Team

K

Kaitlyn Palm

CONTACT

R

Reem Ennenga

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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