Clinical Trial

ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Study acronym: ROBUST-III
Active, Not Recruiting
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Summary
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2018-04-13; most recent amendment 2026-04-27.
Status change: Recruiting → Active, Not Recruiting 2020-06-18
Status change: Not Yet Recruiting → Recruiting 2018-07-31
Trial Details
NCT Number NCT03499964
Lead Sponsor Urotronic Inc.
Collaborators: Laborie Medical Technologies Inc., NAMSA
Conditions Urethral Stricture
Enrollment 127 participants
Start Date 2018-06-22
Primary Completion 2020-12-10 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-19