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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation.
Time frame: up to 120 days after ArtiFix® implantation
Evaluation of CSF leakage rate via MRI at 120 days after ArtiFix® implantation Evaluation of CSF leakage rate via MRI at 330 days after ArtiFix® implantation
Time frame: at 120 and 330 days after ArtiFix® implantation.
To evaluate the frequency and severity of device-related adverse events, up to 330 days post ArtiFix® implantation.
Time frame: up to 330 days post ArtiFix® implantation.
Wound healing at implant site up to 30 days after implantation.
Time frame: Up to 30 days after implantation.
Device Handling Characteristics, as reported by the surgeon [e.g. Ease of Use, Strength, Seal Quality, Reapplication (if occurred), adhesion to surgical tools]. Device Handling Characteristics reported by user experience questionnaire.
Time frame: Following investigational device implantation on the day of the surgical procedure.
Magnetic Resonance Imaging at the 120 and 330 days follow-up, to determine the presence or absence of the following conditions: • Adhesion formation • Scarring • Brain edema adjacent to device implant site
Time frame: At the 120 and 330 days follow-up visits
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