[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556987":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":65,"collaborators":67,"id":73,"slug":13,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":13,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":13,"overallStatus":52,"whyStopped":13,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Novadip Biosciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Long-term safety of the NVDX3 implant","Description of all SAEs, NVDX3 related AEs and AE of special interest","Between screening (V0) and 120 months post-core study (V10)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the \"core NVDX3 trial\"). All patients having signed the ICF enter the long term follow-up study.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"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.",[27],"Drug: NVDX3",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"DRUG","NVDX3","NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)",[23],[35],{"name":36,"affiliation":37,"role":38},"Torsten Gerich, MD","Centre Hospitalier du Luxembourg","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":13,"email":44},"Denis Dufrane, MD","CONTACT","+3210779220","clinical@novadip.com",{"name":46,"role":42,"phone":47,"phoneExt":13,"email":48},"Danielle Gérard, MSc","+32473540008","danielle.gerard@novadip.com",[50],{"facility":51,"status":52,"city":53,"state":13,"zip":54,"country":53,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre Hospitalier de Luxembourg","RECRUITING","Luxembourg","1210","LU",{"type":57,"coordinates":58},"Point",[59,60],6.13268,49.60982,{"lat":60,"lon":59},[63],{"name":36,"role":42,"phone":13,"phoneExt":13,"email":64},"gerich.torsten@chl.lu",{"type":66,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[68,70],{"name":69,"class":6},"PrimeVigilance",{"name":71,"class":72},"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":83,"type":84},15,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","An study evaluating the long-term safety of all patients previously treated with NVDX3.",[91,92],"Distal Radius Fractures","Degenerative Lumbar Spondylolisthesis","2024-09-01",{"date":95,"type":96},"2024-09-05","ACTUAL",{"date":98,"type":96},"2024-08-22",{"date":100,"type":84},"2036-03",{"name":5,"class":6},1]