RecruitingPhase 4

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

United States34 participantsStarted 2022-02-14

Plain-language summary

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Age range22 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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%

✕. 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

Primary Safety Endpoint

Timeframe: 3-months

NCT IDNCT05383274

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Brenda Johnson, MS

Who can participate

Age range22 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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%

✕. 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