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Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
NCT05383274 · View on ClinicalTrials.gov ↗
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05383274
The ClinicalTrials.gov registry entry for NCT05383274 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Urotronic, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05383274 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arkansas, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05383274?
The interventions under investigation include: Optilume Urethral DCB (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05383274?
This trial is sponsored by Urotronic, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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