[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dural-tear\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dural-tear":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651894","a-prospective-randomized-two-arm-controlled-single-blind-multi-center-study-to-evaluate-the-safety-and-efficacy-of-artifix-dural-repair-sealant-graft-in-cranial-and-spine-surgery-neofix-study-100651894",false,"NCT07765862","A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)","NEOFIX","Inclusion Criteria:\n\nPre-operative inclusion criteria:\n\n1. Male or female aged ≥18 and \\\u003C80 years.\n2. Subject is scheduled for an elective cranial or spine surgery with a potential\\[EG4.1\\] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.\n3. Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.\n4. Surgical wound is expected to be Class I\u002Fclean.\n5. Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.\n\n   Intra-operative Inclusion criteria:\n6. CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.\n7. The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.\n\nExclusion Criteria:\n\nPre-operative exclusion criteria:\n\n1. Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.\n2. Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).\n3. Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.\n4. Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.\n5. Subject had a previous surgery in the same anatomical site.\n6. Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.\n7. Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).\n8. Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.\n9. Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever \\> 38.3℃, or positive blood culture.\n10. Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).\n11. Subjected is diagnosed with sepsis, or systemic collagen disease.\n12. Subject at high risk of delayed or failed wound healing due to past treatments or conditions.\n13. Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels \\>1.3 mg\u002FdL.\n14. Subject was diagnosed with liver disease evident by any of the following test results: ALT \\> 55 U\u002FL, AST \\> 48 U\u002FL, ALP \\> 129 U\u002FL, GGT \\> 61 U\u002FL, Total bilirubin \\> 1.3 mg\u002FdL, Albumin \\\u003C 3.5 g\u002FDl, INR \\> 1.2, or PT \\> 15 sec.\n15. Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c \\> 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.\n16. Subject had chemotherapy and\u002For radiotherapy in the past 8 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 8 weeks after surgery.\n17. Subject requires an external ventricular or lumbar CSF drain that must be left in place after surgery.\n18. Subject has congenital or acquired coagulopathy.\n19. The subject was classified as exhibiting drug abuse.\n20. Subject has any condition that, in the Principal Investigator's judgment, may compromise the subject's safety or preclude compliance with the study investigation plan and\u002For device instructions.\n21. Subject is participating in another clinical trial that tests any other drug or device.\n22. Subject is pregnant or breast-feeding at screening or intends to become pregnant during the study period.\n23. Subject has known history of sensitivity or allergy to any component of the ArtiFix®.\n\n    Intra-operative Exclusion criteria:\n24. Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.","ALL","18 Years","80 Years",{"count":20,"type":21},228,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.",[27,28],"CerebroSpinal Fluid (CSF) Leak","Dural Tear","NOT_YET_RECRUITING","2026-08-10",{"date":32,"type":33},"2026-08-14","ACTUAL",{"date":35,"type":21},"2027-01-01",{"date":37,"type":21},"2029-01-01",{"name":39,"class":40},"Nurami Medical Ltd","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100600036","safety-and-efficacy-evaluation-of-artifix-sealant-graft-in-subjects-requiring-dural-repair-following-neurosurgery-100600036","NCT07092267","Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery","A Multiple Center, Prospective, Single-arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery","Inclusion Criteria:\n\n1. Subject between the ages of 22-65 (inclusive)\n2. 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\u002Fclosed 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).\n3. Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.\n4. Surgical wound is expected to be Class I\u002Fclean.\n5. 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.\n\nExclusion Criteria:\n\n1. Subject has known hydrocephalus.\n2. Subject is unable to undergo MRI after the surgery.\n3. Subject's life expectancy is less than 12 months.\n4. Significant intraoperative hemorrhage that mandates blood transfusion.\n5. 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\u002For a positive chest x-ray for acute inflammatory process.\n6. Subject has acquired or congenital compromised immune system and\u002For autoimmune disease, and\u002For is taking chronic immunosuppressant agents at baseline.\n7. Subject will require use of other forms of dural repair (i.e. dural graft or sealant).\n8. Subject is intended to undergo craniectomy wherein bone flap will not be returned.\n9. Subject with a compromised wound healing process due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other concurrent conditions (e.g. long-standing steroids treatment).\n10. Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C\\>6.5%), sepsis, and systemic collagen disease.\n11. Subject had chemotherapy and\u002For radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.\n12. Subject is an acute cranial trauma surgical case or had intracranial hemorrhage from any cause (hemorrhagic stroke, ruptured aneurysm etc.).\n13. Subject that has a concurrent disease or symptoms or conditions that would place the patient in excessive risk to the planned surgery - defined by PI.\n14. Subject had a previous neurosurgery in the same anatomical site.\n15. Subject was diagnosed with clinically significant coagulopathy as determined by the surgeon.\n16. Subject is participating in another clinical trial using investigational devices\u002Fdrugs\n17. Subjects who previously participated in any investigational drug or device study within 30 days of screening\n18. Subject has known history of sensitivity or allergy to any component of the ArtiFix®.\n19. Female subjects who are breastfeeding, pregnant or interested in becoming pregnant during the duration of the study.\n20. Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation.","22 Years","65 Years",{"count":51,"type":21},20,[24],"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.",[55,28],"Cerebrospinal Fluid Leak","2025-08-10",{"date":58,"type":33},"2025-08-14",{"date":60,"type":21},"2025-11",{"date":62,"type":21},"2027-11",{"name":39,"class":40}]