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Urethral DCB for Urethral Stricture(STREAM Trial)
STREAM Trial Summary
This trial is testing a new device to improve semen quality in men.
STREAM Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
STREAM Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
STREAM Trial Design
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Who is running the clinical trial?
- You need to have a high enough amount of sperm in your body.At least 40% of the sperm are able to move.You have had a vasectomy or any other condition that affects your ability to produce semen or ejaculate.You are allergic to paclitaxel or similar drugs.You are currently taking certain medications and have not stopped them for a proper amount of time before starting the study.You have at least 39 million sperm in total.You are willing to participate in the study and comply with study requirements.The movement of your sperm cells is at least 32%.You have a narrow passage in the front part of your urethra that can be treated with the Optilume Urethral DCB as per the approved instructions.Men between 22 and 55 years old.You need to produce at least 1.5 milliliters of semen.You have a narrow area in the front part of your urethra that can be treated with the Optilume Urethral DCB according to the approved instructions.You have had cancer in the past that is not completely gone.More than 4% of your cells have an abnormal shape.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.
- Group 1: Optilume Urethral DCB
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
Do individuals aged 65 and younger qualify for the trial?
"This clinical trial is recruiting participants aged between 22 and 55 years."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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