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Urethral DCB for Urethral Stricture(STREAM Trial)

Phase 4
Led By Karl Coutinho, MD
Research Sponsored by Urotronic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up6-months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

STREAM Trial Summary

This trial is testing a new device to improve semen quality in men.

STREAM Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Men who are between 22 and 65 years old.
You have a narrow passage in your urethra that can be treated with the Optilume Urethral DCB according to the approved instructions.
You need to be able to provide healthy sperm samples for the study.

STREAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety Endpoint
Secondary outcome measures
Secondary Safety Endpoint

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

STREAM Trial Design

1Treatment groups
Experimental Treatment
Group I: Optilume Urethral DCBExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Urotronic Inc.Lead Sponsor
7 Previous Clinical Trials
803 Total Patients Enrolled
4 Trials studying Urethral Stricture
193 Patients Enrolled for Urethral Stricture
Karl Coutinho, MDPrincipal InvestigatorNew Jersey Urology

Media Library

Optilume Urethral DCB (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05383274 — Phase 4
Urethral Stricture Research Study Groups: Optilume Urethral DCB
Urethral Stricture Clinical Trial 2023: Optilume Urethral DCB Highlights & Side Effects. Trial Name: NCT05383274 — Phase 4
Optilume Urethral DCB (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05383274 — Phase 4
Urethral Stricture Patient Testimony for trial: Trial Name: NCT05383274 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still recruiting participants?

"According to the clinicaltrials.gov portal, this trial is open for enrollment and was initially uploaded on February 14th 2022 with its most recent edit occurring May 16th of that same year."

Answered by AI

Could I qualify for participation in this trial?

"Participants in this trial must possess a urethral stricture and be between the ages of 22 to 55. A total of 34 individuals are sought for participation."

Answered by AI

How many health care facilities are currently running this research study?

"At present, this trial is running at 5 medical centres located in Cheektowaga, Tampa and Shreveport as well as two other cities. Prospective participants should consider selecting the closest site to them to minimize travel commitments."

Answered by AI

Has Optilume Urethral DCB been authorized by the FDA?

"Data from the Phase 4 clinical trial led our team to rate Optilume Urethral DCB's safety a 3, given its approval status."

Answered by AI

Do individuals aged 65 and younger qualify for the trial?

"This clinical trial is recruiting participants aged between 22 and 55 years."

Answered by AI

What is the projected number of participants in this trial?

"Affirmative. The clinicaltrials.gov website reveals that the trial, which was launched on February 14th 2022, is looking for participants and has recently been updated (May 16th 2021). This study needs 34 patients to be recruited from 5 hospitals across America."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Florida Urology
Western New York
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I hope this clinical trial help me.
PatientReceived no prior treatments
~0 spots leftby Nov 2023