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Optilume Urethral DCB for Urethral Stricture (STREAM Trial)
Phase 4
Recruiting
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
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
Male subjects between 22 and 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
STREAM Trial Summary
This trial is testing a new device to improve semen quality in men.
Who is the study for?
Men aged 22-65 with urethral stricture and healthy semen parameters (concentration, motility, volume) who can consent to follow-ups. Excluded are those with vasectomies, hypersensitivity to paclitaxel, certain medication use without washout period, unwillingness to abstain or use condoms post-procedure, or a history of cancer not in remission.Check my eligibility
What is being tested?
The study is testing the Optilume Urethral Drug-Coated Balloon (DCB) on men with urethral strictures. It's a single-arm trial focusing on how this treatment affects semen quality after the procedure.See study design
What are the potential side effects?
While specific side effects aren't listed for Optilume Urethral DCB, similar procedures may cause discomfort at the treatment site, urinary issues like infection or retention, and potential impact on sexual function.
STREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a narrow spot in my urethra that can be treated with a specific procedure.
Select...
I am a man aged between 22 and 65.
Select...
I am a man aged between 22 and 55.
STREAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
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
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.
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Who is running the clinical trial?
Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
898 Total Patients Enrolled
4 Trials studying Urethral Stricture
196 Patients Enrolled for Urethral Stricture
Karl Coutinho, MDPrincipal InvestigatorNew Jersey Urology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least 39 million sperm in total.I have a narrow spot in my urethra that can be treated with a specific procedure.I am a man aged between 22 and 65.I agree to use effective birth control for 6 months after the procedure.You need to have a high enough amount of sperm in your body.At least 40% of the sperm are able to move.The movement of your sperm cells is at least 32%.I am a man aged between 22 and 55.You need to produce at least 1.5 milliliters of semen.More than 4% of your cells have an abnormal shape.You need to be able to provide healthy sperm samples for the study.You are allergic to paclitaxel or similar drugs.I have had a vasectomy or a condition affecting sperm production.I am currently on medication like SSRIs or hormone therapy without a break.I am unwilling to abstain from sex or use a condom for 30 days after the procedure.I have a history of cancer that is not fully in remission.
Research Study Groups:
This trial has the following groups:- Group 1: Optilume Urethral DCB
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Pennsylvania
Wisconsin
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Florida Urology
Chesapeake
Western New York
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I hope this clinical trial help me.
PatientReceived no prior treatments
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