Actively Recruiting
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Led by Urotronic Inc. · Updated on 2026-04-28
34
Participants Needed
9
Research Sites
254 weeks
Total Duration
On this page
Sponsors
U
Urotronic Inc.
Lead Sponsor
L
Laborie Medical Technologies Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
CONDITIONS
Official Title
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects between 22 and 65 years of age
- Diagnosed with a stricture in the anterior urethra treatable with the Optilume Urethral DCB according to approved Instructions for Use
- Willing to provide written informed consent and comply with required follow-up assessments
- Able to provide viable semen samples with baseline semen quality above reference values: total sperm ≥39 million, sperm concentration ≥15 million/mL, total motility ≥40%, progressive motility ≥32%, morphology ≥4% (average of 2 samples)
You will not qualify if you...
- Known hypersensitivity to paclitaxel or related compounds
- History of vasectomy or conditions inhibiting semen/sperm production or ejaculatory function
- Currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Unwilling to abstain or use a condom for 30 days after the procedure
- Unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system not in complete remission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
3
Florida Urology
Tampa, Florida, United States, 33615
Actively Recruiting
4
Regional Urology
Shreveport, Louisiana, United States, 71106
Completed
5
Chesapeake
Hanover, Maryland, United States, 21076
Completed
6
Freedman Urology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
7
New Jersey Urolgy
Millburn, New Jersey, United States, 07041
Completed
8
Western New York
Cheektowaga, New York, United States, 14225
Actively Recruiting
9
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
B
Brenda Johnson, MS
CONTACT
R
Reem Ennenga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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