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RecruitingNCT06560476

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

A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Sponsor

Urotronic Inc.

Enrollment

500 participants

Start Date

Mar 30, 2024

Study Type

OBSERVATIONAL

Conditions

Benign Prostatic Hyperplasia

Summary

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

Eligibility

Sex: MALE

Inclusion Criteria1

  • \. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).

Exclusion Criteria5

  • 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
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Interventions

OTHERData collection

Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

Locations(9)

Golden State Urology

Sacramento, California, United States

Florida Urology Partners

Tampa, Florida, United States

Kearney Urology Center

Kearney, Nebraska, United States

The Urology Center, P.C.

Omaha, Nebraska, United States

Sheldon Freedman, Ltd

Las Vegas, Nevada, United States

Northwell Health - Smith Institute of Urology

Syosset, New York, United States

Good Samaritan Hospital

Corvallis, Oregon, United States

Midtown Urology

Austin, Texas, United States

Potomac Urology

Woodridge, Virginia, United States

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NCT06560476

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