Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Recruiting now · Phase 4
Conditions studied: Urethral Stricture
In brief
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Key facts
- Study ID
- NCT05383274
- Run by
- Urotronic Inc.
- People needed
- 34
- Starts
- 2022-02-14
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-04-28
Who can join
Age: 22 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male subjects between 22 and 65 years of age
- 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
- Subject is willing to provide written informed consent and comply with study required follow-up assessments
- Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
- total sperm ≥39 million
- sperm concentration ≥15 million/mL
- total motility ≥40%
- progressive motility ≥32%
- morphology ≥4%
You may not qualify if…
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system that is not considered in complete remission
Where it is running
- Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
- Orlando Health — Orlando, Florida, United States (enrolling)
- Florida Urology — Tampa, Florida, United States (enrolling)
- Freedman Urology — Las Vegas, Nevada, United States (enrolling)
- Western New York — Cheektowaga, New York, United States (enrolling)
- Urology Clinics of North Texas — Dallas, Texas, United States (enrolling)
- Regional Urology — Shreveport, Louisiana, United States
- Chesapeake — Hanover, Maryland, United States
- New Jersey Urolgy — Millburn, New Jersey, United States
Full record on ClinicalTrials.gov
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