[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615043":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens",null,"This cohort consists of donated human cadaveric specimens used to evaluate a range of cranio-spinal neurosurgical approaches. The group serves as an anatomical model to study surgical exposure, technical feasibility, and anatomical variation in a controlled preclinical setting. Procedures will involve macroscopic and microscopic visualization methods and may include testing of new surgical techniques or instruments. Surgeons performing the dissections will provide structured assessments of technical difficulty, visibility, and usability of the approaches.",[13],"Procedure: Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.","This intervention consists of performing standardized cranio-spinal neurosurgical approaches on donated human cadaveric specimens to evaluate surgical exposure, operative feasibility, and anatomical variation in a preclinical setting. The procedures use both macroscopic and microscopic visualization systems. uantitative measurements of exposure area and operative workspace are obtained through dedicated imaging and navigation-based software. The intervention also allows controlled testing of new surgical tools or techniques, with surgeon-reported assessments of difficulty, visibility, and usability. In addition, hands-on dissection sessions are incorporated to support structured surgical training and technical skill development.",[9],[21],"No other names or identifiers; refers only to standardized cranio-spinal neurosurgical approaches on cadaveric specimens",[23],{"name":24,"affiliation":5,"role":25},"Francesco Doglietto","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Francesco Doglietto, MD, PhD","CONTACT","+3906 3015.4120","francesco.doglietto@policlinicogemelli.it",{"name":33,"role":29,"phone":30,"phoneExt":10,"email":34},"Martina Offi, MD","martina.offi@guest.policlinicogemelli.it",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100615043","cranio-spinal-neurosurgical-approaches-100615043",false,"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.","ALL","18 Years",{"count":48,"type":49},35,"ESTIMATED","OBSERVATIONAL","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).",[53,54,55],"Minimally Invasive Techniques","Neurosurgical Procedures","Cadaveric Training",[57,58,59,60,61,62,63,64],"Cranio-spinal surgery","Neurosurgery","Minimally invasive techniques","Surgical validation","Anatomical models","Cadaveric dissection","Neuroanatomy","Surgical training","NOT_YET_RECRUITING","2025-12-13",{"date":68,"type":69},"2025-12-17","ACTUAL",{"date":71,"type":49},"2025-12-30",{"date":73,"type":49},"2028-07-30",{"name":5,"class":6}]