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
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)
View Full Details on ClinicalTrials.gov
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NCT06560476
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