NCT05383274

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Urotronic Inc. · Industry
• Sex: Male
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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 States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Optilume 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.

Timeline

• Start date: 2022-02-14
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2022-05-20
• Last updated: 2025-10-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study