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Adherus™ Dural Sealant in Spinal Procedures

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 24, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study description revisedv15
  2. Primary and study completion dates: Mar 2025 to Dec 2025
    • Study sites: 15 to 14
    v14
  3. Primary and study completion dates: Aug 2024 to Mar 2025
    • Study sites revised (15)
    v13
  4. Collaborator revisedv12
  5. Phase: Phase 3 to Not applicablev11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 2023 to Aug 2024
    • Study completion date: Jul 2024 to Aug 2024
    v10
  2. Study sites: 11 to 15v9
  3. Enrollment target: 256 to 114
    • Study description revised
    • Collaborator revised
    v8
  4. Study sites: 8 to 11v7
  5. Study sites: 7 to 8v6
  6. Re-verified, no change to tracked fieldsv5
  7. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 1 to 7
    • Start date changed from estimate of Nov 2020 to Nov 19, 2020
    v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2020 to Nov 2020
    v3
  9. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
Trial Details
NCT Number NCT04498026
Lead Sponsor Stryker Craniomaxillofacial
Collaborators: Fortrea
Conditions
(from sponsor)		 Spinal Duraplasty
Related terms Cerebrospinal Fluid Otorrhea
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov