[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556987":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":51,"collaborators":53,"id":59,"slug":20,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Novadip Biosciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NVDX3 implant","EXPERIMENTAL","NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size\u002Fintervertebral disc space.",[13],"Drug: NVDX3",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","NVDX3","NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Torsten Gerich, MD","Centre Hospitalier du Luxembourg","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Denis Dufrane, MD","CONTACT","+3210779220","clinical@novadip.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Danielle Gérard, MSc","+32473540008","danielle.gerard@novadip.com",[37],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":40,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Centre Hospitalier de Luxembourg","RECRUITING","Luxembourg","1210",{"type":43,"coordinates":44},"Point",[45,46],6.13268,49.60982,{"lat":46,"lon":45},[49],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":50},"gerich.torsten@chl.lu",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54,56],{"name":55,"class":6},"PrimeVigilance",{"name":57,"class":58},"Data Investigation Company Europe (DICE)","UNKNOWN","100556987",false,"NCT06532253","Long-term Safety Trial with NVDX3","Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.","X3LTFU","Inclusion Criteria:\n\n1. Patient being implanted with NVDX3.\n2. Previously participated to one of the NVDX3 core clinical trials.\n3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years\n4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.\n\nExclusion Criteria:\n\nNo exclusion criteria are applicable.","ALL","18 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","An study evaluating the long-term safety of all patients previously treated with NVDX3.",[77,78],"Distal Radius Fractures","Degenerative Lumbar Spondylolisthesis","2024-09-01",{"date":81,"type":82},"2024-09-05","ACTUAL",{"date":84,"type":82},"2024-08-22",{"date":86,"type":70},"2036-03",{"name":5,"class":6},1]