Clinical Trial

Adherus™ Dural Sealant in Spinal Procedures

Enrolling by Invitation
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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.
Summary
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-07-30; most recent amendment 2025-02-20.
Status change: Recruiting → Enrolling by Invitation 2021-02-03
Status change: Not Yet Recruiting → Recruiting 2020-10-21
Trial Details
NCT Number NCT04498026
Lead Sponsor Stryker Craniomaxillofacial
Collaborators: Fortrea
Conditions Spinal Duraplasty
Enrollment 114 participants
Start Date 2020-11-19
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-24