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.
Male or female aged ≥18 and <80 years.
Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
Surgical wound is expected to be Class I/clean.
Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
Parallel
ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
DeviceArtiFix® is a sterile, synthetic, single use, adhesive, resorbable sealant graft intended to seal and repair dural defects following cranial or spinal surgeries.
Standard of Care (Investigator Choice)
DeviceStandard-of-care for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used)
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
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This trial is not recruiting at the moment. You can still explore other options:
