Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)
Sponsor: Laborie Medical Technologies Inc.
Listed as NCT05383274, this observational or N/A phase trial focuses on Urethral Stricture and remains actively recruiting participants. Sponsored by Laborie Medical Technologies Inc., it has been updated 8 times since 2022, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE4 → None
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Nov 2025 — May 2026 [monthly]
Recruiting PHASE4
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Feb 2025 — Nov 2025 [monthly]
Recruiting PHASE4
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Sep 2024 — Feb 2025 [monthly]
Recruiting PHASE4
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE4
▶ Show 3 earlier versions
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE4
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Feb 2023 — Jun 2024 [monthly]
Recruiting PHASE4
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Jun 2022 — Feb 2023 [monthly]
Recruiting PHASE4
First recorded
Feb 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Contact Information
- Laborie Medical Technologies Inc.
- Urotronic Inc.
For direct contact, visit the study record on ClinicalTrials.gov .