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

Study acronym: ROBUST-III
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: Mar 2026 to Aug 2026
    • Site details revised at 1 of 22 sites
    v25
  2. Re-verified, no change to tracked fieldsv24
  3. Study completion date: Dec 2025 to Mar 2026v23
  4. Collaborators: 1 to 2v22
  5. Results first posted: Jun 6, 2023
    • Primary endpoints revised (2)
    v21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary endpoints revised (2)
    • Secondary endpoints revised (2)
    v20
  2. Secondary endpoints: 3 to 2
    • Primary endpoints revised (2)
    v19
  3. Primary completion date changed from estimate of Dec 2020 to Dec 10, 2020
    • Study completion date: Jun 2025 to Dec 2025
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 1 of 22 sites
    v18
  4. Primary completion date: Nov 2019 to Dec 2020v17 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 127
    • Study completion date: Nov 2024 to Jun 2025
    • Study sites revised (22)
    • Eligibility criteria expanded, about 4 words
  5. Re-verified, no change to tracked fieldsv16
  6. Study sites: 20 to 22v15
  7. Study sites: 19 to 20v14
  8. Study sites revised (19)v13
  9. Study sites: 20 to 19
    • Eligibility criteria shortened, about 11 words
    v12
  10. Study sites: 19 to 20v11
  11. Re-verified, no change to tracked fieldsv10
  12. Study sites: 17 to 19v9
  13. Study sites: 15 to 17v8
  14. Study sites revised (15)v7
  15. Study sites: 10 to 15v6
  16. Study sites: 8 to 10
    • Eligibility criteria expanded, about 23 words
    v5
  17. Study sites: 7 to 8v4
  18. Study sites: 5 to 7v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jun 2018 to Jun 22, 2018
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Urotronic Inc.
6 trials monitored
See 1 trial at risk
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).
Trial Details
NCT Number NCT03499964
Lead Sponsor Urotronic Inc.
Collaborators: Laborie Medical Technologies Inc., NAMSA
Conditions
(from sponsor)		 Urethral Stricture
Related terms Bites and Stings, Lower Urinary Tract Symptoms, Urethral Stricture
Enrollment 127 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov