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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-08-14

No results posted yet for this study

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

Interventions

DEVICE

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

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

DEVICE

Standard of Care (Investigator Choice)

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

Sponsors & Collaborators

  • Nurami Medical Ltd

    lead OTHER

Principal Investigators

  • Joseph Milbaum, MD · Nurami Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-01-01
Completion
2029-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765862 on ClinicalTrials.gov