[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534380":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group experimental","EXPERIMENTAL","The patients included in the study and admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction will benefit from a surgery assisted with the universal surgical device FIBUMAND.",[13],"Device: Universal surgical device FIBUMAND",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Universal surgical device FIBUMAND","This device is made of biocompatible resin for type IIa medical devices with a 3D printer.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Alice PREVOST, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+335 61 77 95 43","prevost.a@chu-toulouse.fr",{"name":31,"role":27,"phone":20,"phoneExt":20,"email":32},"Frédéric LAUWERS, MD","lauwers.f@chu-toulouse.fr",[34],{"facility":35,"status":36,"city":37,"state":20,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"CHU Toulouse","RECRUITING","Toulouse","31000","France","FR",{"type":42,"coordinates":43},"Point",[44,45],1.44367,43.60426,{"lat":45,"lon":44},[48,49,51],{"name":23,"role":27,"phone":20,"phoneExt":20,"email":29},{"name":31,"role":50,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100534380","evaluation-of-an-universal-surgical-device-for-mandibular-reconstruction-100534380",false,"NCT06238076","Evaluation of an Universal Surgical Device for Mandibular Reconstruction.","Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.","FIBUMAND","Inclusion Criteria:\n\n* Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment\n* Patients insured under the French social security system\n* Free and informed consent\n\nExclusion Criteria:\n\n* Lateral mandibular reconstruction without symphysis reconstruction\n* Legally incompetent\n* Inclusion in another protocol of research , involving mandibular reconstruction\n* Pregnant or breastfeeding women","ALL","18 Years",{"count":65,"type":66},19,"ESTIMATED","INTERVENTIONAL",[69],"NA","Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.\n\nSince 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.\n\nThe aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.",[72],"Mandibular Reconstruction",[74,72,75,76,77,78],"Mandible","Computer-Aided Design","Fibular free flap","Computer Assisted three dimensional imaging","Surgical equipment","2025-03-12",{"date":81,"type":82},"2025-03-17","ACTUAL",{"date":84,"type":82},"2024-03-28",{"date":86,"type":66},"2026-05",{"name":5,"class":6},1]