A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)

Study acronym: NEOFIX
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

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  1. Eligibility criteria expanded, about 27 words
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.
Trial Details
NCT Number NCT07765862
Lead Sponsor Nurami Medical Ltd
Conditions
(from sponsor)		 CerebroSpinal Fluid (CSF) Leak, Dural Tear
Enrollment 228 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov