Status: Not yet recruiting
Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
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.
Participants needed: 20
Trial details
Age: 22-65Biological sex: AllType: InterventionalSponsor: Nurami Medical LtdUpdated: Aug 14, 2025
Eligibility criteria
Subject between the ages of 22-65 (inclusive) [+4]
Subject has known hydrocephalus. [+19]