Status:
RECRUITING
OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
Lead Sponsor:
Urotronic Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
Brief 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 Criteria
Inclusion
- 1\. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Exclusion
- 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
Key Trial Info
Start Date :
March 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06560476
Start Date
March 30 2024
End Date
March 30 2027
Last Update
March 10 2025
Active Locations (8)
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1
Golden State Urology
Sacramento, California, United States, 95823
2
Florida Urology Partners
Tampa, Florida, United States, 33615
3
Kearney Urology Center
Kearney, Nebraska, United States, 68847
4
Adult & Pediatric Urology, PC
Omaha, Nebraska, United States, 68144