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NCT05383274 · ClinicalTrials.gov registry record · Phase 4

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

A Phase 4 study of Urethral Stricture, sponsored by Urotronic.

Recruiting
Registry status
Phase 4
Development phase
34
Enrollment target
9
Study locations

NCT05383274: Recruiting Phase 4 study of Urethral Stricture, sponsored by Urotronic.

NCT05383274 is a Phase 4 study of Urethral Stricture that is actively recruiting participants, run by Urotronic. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05383274, a Phase 4 study of Urethral Stricture, is actively recruiting participants, sponsored by Urotronic.

RECRUITING
Registry status
Phase 4
Development phase
34 participants
Enrollment target
9
Study locations

Study Summary

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Primary Outcome

Average Change in Sperm Concentration from baseline to 3-months

Conditions Studied

Interventions

  • COMBINATION_PRODUCT Optilume Urethral DCB

Study Locations (9)

Florida

  • Orlando Health - Orlando
  • Florida Urology - Tampa

Arkansas

  • Arkansas Urology - Little Rock

Louisiana

  • Regional Urology - Shreveport

Maryland

  • Chesapeake - Hanover

Nevada

  • Freedman Urology - Las Vegas

New Jersey

  • New Jersey Urolgy - Millburn

New York

  • Western New York - Cheektowaga

Texas

  • Urology Clinics of North Texas - Dallas

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2022-02-14
Est. Completion 2026-12-30
Phase Phase 4
Urotronic

8 total trials

What NCT05383274 shows while recruiting

NCT05383274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Urethral Stricture appearing as the primary indexed condition, and to 1 intervention - of which Optilume Urethral DCB is the first listed.

NCT05383274 lists 9 locations in 8 states (Florida, Arkansas, Louisiana).

Frequently Asked Questions

What is clinical trial NCT05383274 about?

NCT05383274 is a clinical study titled "Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters". Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

What is the current status of trial NCT05383274?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2022-02-14. Estimated completion is 2026-12-30.

What conditions does trial NCT05383274 study?

This clinical trial studies the following conditions: Urethral Stricture.

What interventions are being tested in trial NCT05383274?

The interventions under investigation include: Optilume Urethral DCB (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05383274?

This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05383274 being conducted?

This trial has 9 study locations across Arkansas, Florida, Louisiana, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Urethral Stricture

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 NCT05383274's enrollment target sits among peer trials

34 1520th of 2000 higher than 474 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT05383274, the US trial registry maintained by the National Library of Medicine. NCT05383274 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.