CerebroSpinal Fluid (CSF) Leak, Dural Tear
Conditions
Brief summary
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.
Interventions
ArtiFix® 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 for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used)
Sponsors
Nurami Medical Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Pre-operative inclusion criteria: 1. Male or female aged ≥18 and \<80 years. 2. 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. 3. Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening. 4. Surgical wound is expected to be Class I/clean. 5. Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests. Intra-operative Inclusion criteria: 6. CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver. 7. The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.
Exclusion criteria
Pre-operative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation. | at 120 days after ArtiFix® or control implantation |
Contacts
CONTACTAmir Bahar
CONTACTJenny Krupko
STUDY_DIRECTORJoseph Milbaum, MD
Nurami Medical
Outcome results
None listed