Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Study Overview
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Brief Summary
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Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Detailed Description
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Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.

Official Title
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Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Conditions
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Urethral Stricture

Intervention / Treatment
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* Combination Product: Optilume Urethral DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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% Exclusion Criteria: Subjects with a known hypersensitivity to paclitaxel or structurally related compounds Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function Subjects 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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optilume Urethral DCB<br>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. | Combination Product: Optilume Urethral DCB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Average Change in Sperm Concentration from baseline to 3-months | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint | Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months | 6-months |