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NCT06312722 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
A NA study of Benign Prostatic Hyperplasia, sponsored by Urotronic.
- Recruiting
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 5
- Study locations
NCT06312722: Recruiting NA study of Benign Prostatic Hyperplasia, sponsored by Urotronic.
NCT06312722 is a NA study of Benign Prostatic Hyperplasia that is actively recruiting participants, run by Urotronic. The registered enrollment target is 92 participants, below the 549-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (83% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06312722, a NA study of Benign Prostatic Hyperplasia, is actively recruiting participants, sponsored by Urotronic.
- RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Primary Outcome
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. The first seven questions in the International Prostate Symptom Score (IPSS) questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Conditions Studied
Interventions
- DEVICE Optilume® BPH Catheter System
Study Locations (5)
Arkansas
- Arkansas Urology - Little Rock
Florida
- Florida Urology Partners, LLP - Tampa
Louisiana
- Ochsner LSU Health Shreveport - Regional Urology - Shreveport
Nevada
- Sheldon Freedman MD, Ltd - Las Vegas
Texas
- Midtown Urology Associates - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2031-02-07 |
| Phase | NA |
What NCT06312722 shows while recruiting
NCT06312722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 549-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 1 intervention - of which Optilume® BPH Catheter System is the first listed.
NCT06312722 lists 5 locations in 5 states (Arkansas, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT06312722 about?
NCT06312722 is a clinical study titled "Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study". The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
What is the current status of trial NCT06312722?
This trial is currently recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2024-02-07. Estimated completion is 2031-02-07.
What conditions does trial NCT06312722 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT06312722?
The interventions under investigation include: Optilume® BPH Catheter System (DEVICE).
Who is sponsoring clinical trial NCT06312722?
This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06312722 being conducted?
This trial has 5 study locations across Arkansas, Florida, Louisiana, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Benign Prostatic Hyperplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06312722's enrollment target sits among peer trials
92 22nd of 29 higher than 8 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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