Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorNurami Medical Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Nurami Medical Ltd
Lead sponsor
KCRI
Collaborator
Source ClinicalTrials.gov