NCT07092267

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

A Multiple Center, Prospective, Single-arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nurami Medical Ltd · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebrospinal Fluid Leak
• Dural Tear

Interventions

Type	Name	Description
DEVICE	ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.	ArtiFix® is a synthetic surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. ArtiFix® adheres to the dura, so that sutures are not required to prevent cerebrospinal fluid (CSF) leakage.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-07-29
• Last updated: 2025-08-14