Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

• ClinicalTrials.gov Identifier: NCT05383274
• Recruitment Status: Recruiting
• First Posted: May 20, 2022
• Last Update Posted: January 30, 2023
• Sponsor: Urotronic Inc.
• Information provided by (Responsible Party): Urotronic Inc.

Tracking Information

• First Submitted Date: May 16, 2022
• First Posted Date: May 20, 2022
• Last Update Posted Date: January 30, 2023
• Actual Study Start Date: February 14, 2022
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 16, 2022)

Primary Safety Endpoint [ Time Frame: 3-months ]

Average Change in Sperm Concentration from baseline to 3-months

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 16, 2022)

Secondary Safety Endpoint [ Time Frame: 6-months ]

Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
• Official Title: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
• Brief Summary: 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: 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urethral Stricture

Intervention

Combination Product: Optilume Urethral DCB

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.

Study Arms

Experimental: Optilume Urethral DCB

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.

Intervention: Combination Product: Optilume Urethral DCB

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 16, 2022): 34
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2024
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Men between 22 and 65 years of age.

• Ages: 22 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Brenda Johnson; 17632857488; johnsonb@urotronic.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05383274
• Other Study ID Numbers: PR1275
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Urotronic Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Urotronic Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karl Coutinho, MD; New Jersey Urology

• PRS Account: Urotronic Inc.
• Verification Date: January 2023