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)

NCT07765862 | Not Yet Recruiting

• 1 other identifier: PLN-0000265
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CerebroSpinal Fluid (CSF) Leak; Dural Tear

Outcome Measures

Primary Outcomes (2)

• 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

• The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.

  at 120 days after ArtiFix® implantation.

Study Arms (2)

ArtiFix the investigational device

EXPERIMENTAL

Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.

Standard of care treatment

ACTIVE COMPARATOR

Device: Standard of Care (Investigator Choice)

Interventions

ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. DEVICE

ArtiFix® is a sterile, synthetic, single use, adhesive, resorbable sealant graft intended to seal and repair dural defects following cranial or spinal surgeries.

ArtiFix the investigational device

Standard of Care (Investigator Choice) DEVICE

Standard-of-care for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used)

Standard of care treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.
• 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.

You may not qualify if:

• 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.
• Subject had a previous surgery in the same anatomical site.
• Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.
• Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).
• Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.
• Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever \> 38.3℃, or positive blood culture.
• Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).
• Subjected is diagnosed with sepsis, or systemic collagen disease.
• Subject at high risk of delayed or failed wound healing due to past treatments or conditions.
• Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels \>1.3 mg/dL.
• Subject was diagnosed with liver disease evident by any of the following test results: ALT \> 55 U/L, AST \> 48 U/L, ALP \> 129 U/L, GGT \> 61 U/L, Total bilirubin \> 1.3 mg/dL, Albumin \< 3.5 g/Dl, INR \> 1.2, or PT \> 15 sec.
• Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c \> 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.

Sponsors & Collaborators

• Nurami Medical Ltd: lead

Study Officials

• Joseph Milbaum, MD

  Nurami Medical

  STUDY DIRECTOR

Central Study Contacts

Amir Bahar

CONTACT

+972-54-4487673; amir@nurami-medical.com

Jenny Krupko

CONTACT

0505968319; jenny@nurami-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08