Clinical Trial

Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

Not Yet Recruiting
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Summary
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-22.
Trial Details
NCT Number NCT07092267
Lead Sponsor Nurami Medical Ltd
Collaborators: KCRI
Conditions Cerebrospinal Fluid Leak, Dural Tear
Enrollment 20 participants
Start Date 2025-11
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2025-08-14