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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Optilume Urethral DCB for people with urethral stricture. The study is currently recruiting participants at 9 locations. People eligible for this study include men aged 22 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.