[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebrospinal-fluid-csf-leak\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebrospinal-fluid-csf-leak":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,78,105],{"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":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100624596","analysis-of-cerebrospinal-fluid-leakage-after-surgery-for-intracranial-tumors-100624596","NCT07411690","Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors","Cerebrospinal Fluid Leak Incidence, Management and Risk Factor After Supratentorial Craniotomy for Intracranial Tumors: a Prospective Observational Study.","CSF-IMR","Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Qualified for a craniotomy due to supratentorial intracranial tumor\n\nExclusion Criteria:\n\n* Revision surgery due to recurrent brain tumor\n* Emergency neurosurgical procedure",{"count":50,"type":21},200,"6 Weeks","OBSERVATIONAL","Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.",[55,56,27,57,58,59,60],"Brain Tumor Adult","Brain Tumor Benign","Craniotomy","Glioblastoma","Glioma","Meningioma",[62,63,64,65,66],"intracranial tumor","cerebrospinal fluid leak","supratentorial craniotomy","glioma","meningioma","RECRUITING","2026-05-19",{"date":70,"type":33},"2026-05-22",{"date":72,"type":33},"2026-02-03",{"date":74,"type":21},"2028-04",{"name":76,"class":40},"Medical University of Warsaw",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":77},"100609559","noseal-trial-comparing-sealants-versus-no-sealant-for-preventing-csf-leak-after-endonasal-skull-base-surgery-100609559","NCT07216157","NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery","The NoSeal Trial - Nasal Outcome Study Evaluating Artificial Leak-Sealing: A Prospective, Randomized, Controlled, Single-Blinded, Single-Center Clinical Trial Comparing Fibrin Glue (Tisseel®) and a Two-Component Synthetic Polymer Sealant (PEI\u002FPEG, Adherus®) Versus No Sealant for the Prevention of Cerebrospinal Fluid Leak and Promotion of Wound Healing Following Endonasal Skull Base Surgery, Designed in Accordance With the SPIRIT 2025 Guidelines","NoSeal","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction\n* Informed written consent obtained prior to enrollment\n* Hemodynamic and electrolyte stability before surgery\n* Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques\n\nExclusion Criteria:\n\n* Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)\n* Tumors requiring complex sella reconstruction from the start\n* Preoperative hydrocephalus\n* Known allergy to fibrin-based or synthetic sealant components\n* Active sinus infection or systemic inflammatory disease\n* Prior radiotherapy to the sellar or parasellar region\n* Uncontrolled diabetes mellitus (HbA1c \\> 7.0%)\n* Participation in another interventional trial that may influence wound healing or CSF assessment\n* Radiologic signs of chronic intracranial hypertension or hypotension",{"count":87,"type":21},225,[24],"Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI\u002FPEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.",[27],[92,93,94,95],"csf","pituitary adenoma","csf leak","sealant","2025-10-09",{"date":98,"type":33},"2025-10-14",{"date":100,"type":33},"2025-08-15",{"date":102,"type":21},"2027-03-15",{"name":104,"class":40},"Maria Sklodowska-Curie National Research Institute of Oncology",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":114,"studyType":52,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":77},"100570783","the-freiburg-registry-on-spontaneous-intercranial-hypotension-sih--post-dural-puncture-headache-pdph-100570783","NCT06711731","The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)","SEAL","Inclusion Criteria:\n\n1. Patients with suspected spinal CSF leak based on one of the following\n\n   * History of new orthostatic symptomes with or without prior spinal procedure\n   * Imaging suggestive for spinal CSF leak\n2. Informed consent\n\nExclusion Criteria:\n\na) Symptoms beeing conclusively explained by another known diagnosis",{"count":113,"type":21},2000,"24 Months","Spinal CSF leaks are considered as rare disease. They cause a variety of symptoms, mainly culminating in a chronic headache syndrome. Crucially, yet often disregarded, the disease holds the potential for cure. The multitude of symptoms, and their inconsistency over time are just two of many challenges preventing timely diagnosis and treatment in many patients.\n\nSpinal CSF leaks can occur after intentional or accidental dural puncture (post-dural puncture headache - PDPH) or spontaneously (spontaneous intracranial hypotension - SIH). Awareness is steadily increasing with simultaneous increase of recognized patients. Yet, research and diagnostic is mainly provided by few specialized centers, as e.g. Freiburg. Thus, many observations point towards a large non-diagnosed and non-recognized number of patients, most likely being misdiagnosed and mistreated.\n\nObjective: The aim of the registry is to collect structured information on the frequency, cause, symptoms, diagnostic procedures, treatment options and long-term outcome. With the help of the registry, we would like to contribute to a better understanding and treatment of the diseases.\n\nMethods: Prospective, longitudinal registry on patients with suspected SIH or PDPH, including data on demographics, clinical presentation, diagnostic findings, treatment, at treatment outcome.",[27],[118,119,120,121,122,123,124,125,126,127],"SIH","PDPH","Spinal leaks","CSF leak","SLEC","Spontaneouse Intercranial Hypotension","CSF-venous fistula","Post Dural Puncture Headache","Cerebrospinal Fluid Leak","Rare disease","2024-11-26",{"date":130,"type":33},"2024-12-02",{"date":132,"type":33},"2024-11-04",{"date":134,"type":21},"2036-12-04",{"name":136,"class":40},"University Hospital Freiburg"]