RecruitingPhase 4NCT05383274

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Sponsor

Urotronic Inc.

Enrollment

34 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Urethral Stricture

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: MALEMin Age: 22 YearsMax Age: 65 Years

Inclusion Criteria9

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 Criteria6

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

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Interventions

COMBINATION_PRODUCTOptilume 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.