[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurosurgical-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurosurgical-procedures":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100615043","cranio-spinal-neurosurgical-approaches-100615043","NCT07287462","Cranio-spinal Neurosurgical Approaches","Cranio-spinal Neurosurgical Approaches: Qualitative and Quantitative Analysis and Validation of New Minimally Invasive Methods on Cadaveric Anatomical Models.","Neuro_SURGEM","Inclusion Criteria\n\n* Cadaveric specimens from individuals who provided informed consent for post-mortem donation of their body or tissues for scientific research.\n* Specimens that meet all legal requirements for anatomical donation under Italian Law No. 10\u002F2020 and Presidential Decree (DPR) No. 47\u002F2023.\n* Specimens that are available for the full duration of the study and suitable for performing multiple cranio-spinal surgical approaches.\n\nExclusion Criteria\n\n* Specimens that do not meet the legal or ethical requirements for anatomical donation as defined by Italian regulations.\n* Cadavers with major anatomical deformities, advanced tissue degradation, or pathological conditions that would interfere with surgical dissection or measurement accuracy.\n* Specimens lacking adequate documentation or verified donor consent for post-mortem donation.",{"count":57,"type":21},35,"The goal of this observational study is to learn how different cranio-spinal surgical approaches work and how much anatomical exposure each technique provides in donated human cadaver specimens. The study also aims to understand anatomical variations and to evaluate new surgical techniques and tools that may improve neurosurgical training and practice.\n\nThe main questions it aims to answer are:\n\n* How much surgical exposure area and volume of work does each cranio-spinal approach allow?\n* How do anatomical variations influence the effectiveness and feasibility of different approaches? Researchers will also compare results obtained using different surgical visualization methods (such as the surgical microscope approach or macroscopic evaluation) to see if any method improves visibility or operative efficiency.\n\nCadaveric specimens will undergo:\n\n* Step-by-step cranio-spinal surgical approaches performed by trained neurosurgeons.\n* Quantitative measurements of exposed anatomical areas using imaging software (BrainChop).\n* Assessment of operative time, perceived difficulty by surgeons, and visibility of target anatomical structures.\n* Testing of new surgical instruments or techniques when applicable, without involving any drugs or medical devices.\n\nThis study follows Italian regulations on post-mortem body donation for scientific research (Law No. 10\u002F2020) and is conducted at a single research center recognized as an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico-Scientific Institute for Hospitalization and Care).",[60,27,61],"Minimally Invasive Techniques","Cadaveric Training",[63,64,65,66,67,68,69,70],"Cranio-spinal surgery","Neurosurgery","Minimally invasive techniques","Surgical validation","Anatomical models","Cadaveric dissection","Neuroanatomy","Surgical training","NOT_YET_RECRUITING","2025-12-13",{"date":74,"type":39},"2025-12-17",{"date":76,"type":21},"2025-12-30",{"date":78,"type":21},"2028-07-30",{"name":80,"class":81},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER"]