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 range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.
. 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.