Status:
RECRUITING
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Lead Sponsor:
Urotronic Inc.
Collaborating Sponsors:
Laborie Medical Technologies Inc.
Conditions:
Urethral Stricture
Eligibility:
MALE
22-65 years
Phase:
PHASE4
Brief Summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Detailed Description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United Sta...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05383274
Start Date
February 14 2022
End Date
December 30 2026
Last Update
October 9 2025
Active Locations (9)
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1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
2
Orlando Health
Orlando, Florida, United States, 32806
3
Florida Urology
Tampa, Florida, United States, 33615
4
Regional Urology
Shreveport, Louisiana, United States, 71106