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Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

NCT05383274 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Conditions

  • Urethral Stricture

Interventions

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.

Sponsors & Collaborators

  • Laborie Medical Technologies Inc.

    collaborator INDUSTRY

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Coutinho, MD · New Jersey Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2026-06-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383274 on ClinicalTrials.gov