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Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

NCT07092267 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-14

No results posted yet for this study

Summary

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 spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.

Conditions

  • Cerebrospinal Fluid 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 synthetic surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. ArtiFix® adheres to the dura, so that sutures are not required to prevent cerebrospinal fluid (CSF) leakage.

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Nurami Medical Ltd

    lead OTHER

Principal Investigators

  • Joseph Milbaum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-11-30
Completion
2027-11-30

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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 NCT07092267 on ClinicalTrials.gov