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A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 25, 2026 (before its estimated September 28, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 30, 2026 → Sep 28, 2026
See other at-risk trials from Ethicon, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Site details revised at 7 of 7 sites
  2. Minor Re-verified, no change to tracked fieldsv27
  3. Minor Primary completion pushed from Jun 30, 2026 to Sep 28, 2026
    • Study completion pushed from Jul 30, 2026 to Sep 28, 2026
    v26
  4. Minor 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv24-v25
  5. Minor Primary completion pushed from Mar 31, 2026 to Jun 30, 2026
    • Study completion pushed from Apr 30, 2026 to Jul 30, 2026
    • Study sites: 8 to 7
    v23
Show 21 earlier versionsHide 21 earlier versions
  1. Minor Study sites revised (8)v22
  2. Minor 2 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv20-v21
  3. Notable Primary endpoint revised
    • Primary completion date: Jan 30, 2026 to Mar 31, 2026
    • Study completion date: Feb 28, 2026 to Apr 30, 2026
    • Secondary endpoints: 10 to 11
    v19
  4. Minor Site details revised at 2 of 8 sitesv18
  5. Minor Site details revised at 2 of 8 sitesv17
  6. Minor 2 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv15-v16
  7. Minor Study sites: 7 to 8
    • Secondary endpoints: 12 to 10
    v14
  8. Minor Site details revised at 1 of 7 sitesv13
  9. Minor Primary completion date: Sep 30, 2025 to Jan 30, 2026
    • Study completion date: Mar 1, 2026 to Feb 28, 2026
    v12
  10. Minor Study sites: 6 to 7
    • Primary completion date: Jan 30, 2026 to Sep 30, 2025
    • Secondary endpoints: 10 to 12
    v11
  11. Minor Primary completion date: Sep 30, 2025 to Jan 30, 2026
    • Secondary endpoints: 12 to 10
    v10
  12. Minor Study sites: 5 to 6v9
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Nov 11, 2025 to Mar 1, 2026
    • Start date changed from estimate of Apr 14, 2025 to Apr 16, 2025
    • Site details revised at 5 of 5 sites
    v8
  14. Minor Start date: Mar 17, 2025 to Apr 14, 2025v7
  15. Minor Study sites: 4 to 5v6
  16. Notable Start date: Feb 7, 2025 to Mar 17, 2025v5
  17. Minor Re-verified, no change to tracked fieldsv4
  18. Notable Lead sponsor: [Redacted] to Ethicon, Inc.v3 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Sep 30, 2025
    • Study completion date: Nov 11, 2025
    • Start date: Feb 7, 2025
    • Study title expanded, about 2 words
  19. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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.
9 trials monitored
See 1 trial at risk
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
Trial Details
NCT Number NCT06664788
Lead Sponsor Ethicon, Inc.
Conditions
(from sponsor)
Hemostasis, Hemostatic Techniques
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov