[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebrospinal-fluid-leak\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebrospinal-fluid-leak":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641716","immiseal-dural-sealant-post-market-registry-study-100641716",false,"NCT07651826","Immiseal™ Dural Sealant Post-Market Registry Study","Multicentre, Prospective, Post-Market, Observational Registry Study to Observe the Performance and Safety of the Immiseal™ Dural Sealant System for Use as an Adjunct to Standard Methods of Dural Repair to Provide Watertight Closure During Neurosurgical Procedures","Inclusion Criteria:\n\n1. Age 18 to 75 years old, regardless of gender.\n2. Patients diagnosed with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, or spinal canal disease, who undergo neurosurgical procedures such as posterior fossa surgery or other interventions resulting in dural defects, whether due to surgery or accidental injury, and who present with, or are at risk of, cerebrospinal fluid (CSF) leakage requiring auxiliary dural repair.\n3. Patients willing to comply with the requirements of the clinical investigation by signing the informed consent.\n4. Female patients of childbearing potential must use highly effective contraceptive methods for the duration of the study. Highly effective contraceptive methods include hormonal contraception, intrauterine device, or sexual abstinence.\n\nExclusion Criteria:\n\n1. Immiseal™ Dural Sealant System is not to be used in confined bone structures where nerves are present, since neural compression may result due to hydrogel swelling.\n2. Patients with an active infection present at the surgical site.\n3. Patients with life expectancy less than 3 months.\n4. Female patients who are pregnant, planning pregnancy, breastfeeding, and\u002For unwilling to use adequate contraception during the trial.","ALL","18 Years","75 Years",{"count":20,"type":21},85,"ESTIMATED","OBSERVATIONAL","This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.",[25,26,27],"Dural Defect","Cerebrospinal Fluid Leak","Neurosurgical Procedures",[29,30,31,26,32,33,25,34],"Immiseal","Dural sealant","Dural repair","Surgical site infection","Post-market clinical follow-up","Neurosurgical Procedure","RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-16","ACTUAL",{"date":41,"type":39},"2026-02-17",{"date":43,"type":21},"2026-11-23",{"name":45,"class":46},"Medprin Regenerative Medical Technologies Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"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":58,"type":21},20,"INTERVENTIONAL",[61],"NA","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.",[26,64],"Dural Tear","NOT_YET_RECRUITING","2025-08-10",{"date":68,"type":39},"2025-08-14",{"date":70,"type":21},"2025-11",{"date":72,"type":21},"2027-11",{"name":74,"class":75},"Nurami Medical Ltd","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":59,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100554326","effect-of-spinal-needle-type-on-optic-nerve-sheath-diameter-100554326","NCT06497634","Effect of Spinal Needle Type on Optic Nerve Sheath Diameter","Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I-II Risk Classification\n* Elective orthopedic lower extremity surgery\n* Using a tourniquet\n* Spinal anesthesia\n\nExclusion Criteria:\n\n* Bilateral tourniquet usage\n* History of orbital trauma\n* Optic nerve pathology\n* Glaucoma\n* Asthma\n* Coronary obstructive or pulmonary disease\n* Previous corneal or intraocular surgery\n* Increased intracranial pressure\n* Coagulopathy\n* Local site infection\n* Refusing to participate in the study","40 Years",{"count":85,"type":21},165,[61],"The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.",[89,90,91,92,26],"Spinal Anesthesia","Intracranial Pressure Change","Optic Nerve Sheath Diameter","Orthopedic Surgery","2024-07-29",{"date":95,"type":39},"2024-07-30",{"date":97,"type":21},"2024-08-15",{"date":99,"type":21},"2024-12-30",{"name":101,"class":102},"Bagcilar Training and Research Hospital","OTHER_GOV"]