Ireland
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Active, not recruiting Phase 4

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

NCT05383274 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2022-02-14
Last updated
2026-09-21

Condition(s) studied

Urethral Stricture

Investigational drug(s) / intervention(s)

Optilume Urethral DCB

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

Sex
MALE
Min age
22 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male subjects between 22 and 65 years of age 2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use 3. Subject is willing to provide written informed consent and comply with study required follow-up assessments 4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples): 1. total sperm ≥39 million 2. sperm concentration ≥15 million/mL 3. total motility ≥40% 4. progressive motility ≥32% 5. morphology ≥4% Exclusion Criteria: 1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds 2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function 3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout 4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure 5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential 6. History of cancer in any body system that is not considered in complete remission

Primary outcome measure(s)

  • Primary Safety Endpoint — 3-months
    Average Change in Sperm Concentration from baseline to 3-months

Trial sites (9)

FacilityCityRegionStatus
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
Official registry record

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