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New treatment option for Urethral Stricture
Official title Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
ClinicalTrials.gov ID: NCT05383274
What this study is testing
What is Optilume Urethral DCB?
Optilume Urethral DCB is an investigational medicine, being studied as a potential treatment for urethral stricture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65, men only
You may be able to join if
- Male people 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...
- Subject is willing to provide written informed consent and comply with study required follow-up assessments
- Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average...
- total sperm ≥39 million
You likely can't join if
- people with a known hypersensitivity to paclitaxel or structurally related compounds
- people with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- people currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without...
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system that is not considered in complete remission
See the full eligibility criteria
- Male people 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
- Subject is willing to provide written informed consent and comply with study required follow-up assessments
- Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
- total sperm ≥39 million
- sperm concentration ≥15 million/mL
- total motility ≥40%
- progressive motility ≥32%
- morphology ≥4%
- people with a known hypersensitivity to paclitaxel or structurally related compounds
- people with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- people currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system that is not considered in complete remission
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Shreveport, Louisiana, United States
- Hanover, Maryland, United States
- Las Vegas, Nevada, United States
- Millburn, New Jersey, United States
- Cheektowaga, New York, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Orlando, Florida, United States; Tampa, Florida, United States; Shreveport, Louisiana, United States; Hanover, Maryland, United States; Las Vegas, Nevada, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.