Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Follo… (NCT07092267) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
20 participantsStarted 2025-11
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subject between the ages of 22-65 (inclusive)
✓. Subject is scheduled for an elective cranial or spinal surgery with a single dural defect that could not be completely repaired by primary suture. The dural defect must not exceed 6cm2 (e.g. defects of sizes 2cm X 3cm, 1cm X 5cm, can be included). The defect can be completely repaired/closed by a dural sealant graft with an overlap of 6 mm with the surrounding intact dura (only 1 graft can be implanted in each subject in a single location).
✓. Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.
✓. Surgical wound is expected to be Class I/clean.
✓. Subject understands the study requirements and procedures, can provide written Informed Consent and is able and willing to adhere to the required follow-up visits and testing.
Exclusion criteria
✕. Subject has known hydrocephalus.
✕. Subject is unable to undergo MRI after the surgery.
✕. Subject's life expectancy is less than 12 months.
✕. Significant intraoperative hemorrhage that mandates blood transfusion.
✕. Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia etc.) or evidence of any surgical site infection, fever \> 38.3°C, positive blood culture and/or a positive chest x-ray for acute inflammatory process.
✕
What they're measuring
1
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation.
Timeframe: up to 120 days after ArtiFix® implantation
. Subject has acquired or congenital compromised immune system and/or autoimmune disease, and/or is taking chronic immunosuppressant agents at baseline.
✕. Subject will require use of other forms of dural repair (i.e. dural graft or sealant).
✕. Subject is intended to undergo craniectomy wherein bone flap will not be returned.