Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Condition(s) studied
Investigational drug(s) / intervention(s)
Optilume Urethral DCB: The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
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.
Eligibility
Primary outcome measure(s)
- Primary Safety Endpoint — 3-months
Average Change in Sperm Concentration from baseline to 3-months
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Urology | Little Rock | Arkansas | |
| Orlando Health | Orlando | Florida | |
| Florida Urology | Tampa | Florida | |
| Regional Urology | Shreveport | Louisiana | |
| Chesapeake | Hanover | Maryland | |
| Freedman Urology | Las Vegas | Nevada | |
| New Jersey Urolgy | Millburn | New Jersey | |
| Western New York | Cheektowaga | New York | |
| Urology Clinics of North Texas | Dallas | Texas |
More Urotronic Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05383274 on ClinicalTrials.gov ↗ ← All trials in the USA