Urethral Stricture Clinical Trial
— STREAMOfficial title:
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Verified date | May 2024 |
Source | Urotronic Inc. |
Contact | Brenda Johnson |
Phone | 17632857488 |
bjohnson[@]laborie.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | March 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 22 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male subjects between 22 and 65 years of age 2. 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 3. Subject is willing to provide written informed consent and comply with study required follow-up assessments 4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples): 1. total sperm =39 million 2. sperm concentration =15 million/mL 3. total motility =40% 4. progressive motility =32% 5. morphology =4% Exclusion Criteria: 1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds 2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function 3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout 4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure 5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential 6. History of cancer in any body system that is not considered in complete remission |
Country | Name | City | State |
---|---|---|---|
United States | Western New York | Cheektowaga | New York |
United States | Urology Clinics of North Texas | Dallas | Texas |
United States | Chesapeake | Hanover | Maryland |
United States | Freedman Urology | Las Vegas | Nevada |
United States | Arkansas Urology | Little Rock | Arkansas |
United States | New Jersey Urolgy | Millburn | New Jersey |
United States | Orlando Health | Orlando | Florida |
United States | Regional Urology | Shreveport | Louisiana |
United States | Florida Urology | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Urotronic Inc. | Laborie Medical Technologies Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Safety Endpoint | Average Change in Sperm Concentration from baseline to 3-months | 3-months | |
Secondary | Secondary Safety Endpoint | Proportion of Subjects Experiencing =50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months | 6-months |
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