Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

  • Clinical Trial Information

    Trial Contact: Britton, David

    Trial Phone: 321.841.2684

  • IRB No: SSU00239437

    Protocol Abbrev: STREAM

    Principal Investigator: Lucas Wiegand, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: PR1275-001

    Treatment: 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. ID: NCT05383274

  • Objective

    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.

  • Key Eligibility

    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