Clinical trials: Dural Tear, active
CerebroSpinal Fluid (CSF) Leak, Dural Tear
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)
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…
- Trial name
- NEOFIX (NCT07765862)
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries., Standard of Care (Investigator Choice)
- Volunteers
- 228 people
- Sponsor
- Nurami Medical Ltd
Cerebrospinal Fluid Leak, Dural Tear
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…
- Trial name
- NCT07092267
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
- Volunteers
- 20 people
- Sponsor
- Nurami Medical Ltd