Optilume Urethral DCB for Urethral Stricture

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Chesapeake, Hanover, MD
Urethral Stricture
Optilume Urethral DCB - CombinationProduct
Eligibility
18 - 65
Male
What conditions do you have?
Select

Study Summary

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 55 years of age.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6-months

3-months
Primary Safety Endpoint
6-months
Secondary Safety Endpoint

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Optilume Urethral DCB
1 of 1
Experimental Treatment

34 Total Participants · 1 Treatment Group

Primary Treatment: Optilume Urethral DCB · No Placebo Group · Phase 4

Optilume Urethral DCB
CombinationProduct
Experimental Group · 1 Intervention: Optilume Urethral DCB · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-months
Closest Location: Chesapeake · Hanover, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2018First Recorded Clinical Trial
1 TrialsResearching Urethral Stricture
1 CompletedClinical Trials

Who is running the clinical trial?

Urotronic Inc.Lead Sponsor
6 Previous Clinical Trials
778 Total Patients Enrolled
3 Trials studying Urethral Stricture
143 Patients Enrolled for Urethral Stricture
Karl Coutinho, MDPrincipal InvestigatorNew Jersey Urology

Eligibility Criteria

Age 18 - 65 · Male Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have 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.
You are willing to participate in the study and comply with study requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.