OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
NCT ID: NCT06560476
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-03-30
2027-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study Arm
This is the data collection study arm. There is no other arm in the study.
Data collection
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
Interventions
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Data collection
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
3. Confirmed or suspected malignancy of prostate or bladder.
4. Active urinary tract infection (UTI)
5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
MALE
No
Sponsors
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Urotronic Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR1326
Identifier Type: -
Identifier Source: org_study_id
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