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Onyx™ Liquid Embolic IDE Clinical Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 19 to 20
  2. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised at 6 of 19 sites
    • Study description shortened, about 1 word
  3. Study sites: 18 to 19v22
  4. Site details revised at 1 of 18 sitesv21
  5. Study sites: 16 to 18v20
  6. Primary completion pushed from Nov 2026 to Apr 2027
    • Study completion pushed from Dec 2026 to May 2027
    • Study sites: 14 to 16
    v19
  7. Site details revised at 1 of 14 sitesv18
  8. Study sites: 13 to 14v17
  9. Study sites: 12 to 13v16
  10. Study sites: 10 to 12v15
  11. Study sites: 9 to 10v14
  12. Site details revised at 1 of 9 sitesv13
  13. Site details revised at 1 of 9 sitesv12
  14. Study sites: 8 to 9v11
  15. Site details revised at 1 of 8 sitesv10
  16. Study sites: 7 to 8v9
  17. Study sites: 6 to 7v8
  18. Study sites: 4 to 6v7
  19. Study sites: 3 to 4v6
  20. Study sites: 2 to 3
    • Start date changed from estimate of May 2025 to May 9, 2025
    v5
  21. Study sites: 1 to 2v4
  22. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 2026 to Nov 2026
    • Study completion date: Oct 2026 to Dec 2026
    • Start date: Apr 2025 to May 2025
  23. Start date: Mar 2025 to Apr 2025v2
  24. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
Trial Details
NCT Number NCT06742801
Lead Sponsor Medtronic Endovascular
Conditions
(from sponsor)		 Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer, Hemorrhage
Related terms Gastrointestinal Hemorrhage, Hemorrhage, Ulcer, Wounds and Injuries
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov