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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
DeviceArtiFix® 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Subjects requiring Dural repair during elective neurosurgery procedures.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation.
Time frame
up to 120 days after ArtiFix® implantationSecondary outcomes
1
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.2
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.3
Wound healing at implant site up to 30 days after implantation.
Time frame
Up to 30 days after implantation.4
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nurami Medical Ltd
Lead sponsor
KCRI
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: