[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556987":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":52,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"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,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centre Hospitalier de Luxembourg","RECRUITING","Luxembourg","1210","LU",{"type":44,"coordinates":45},"Point",[46,47],6.13268,49.60982,{"lat":47,"lon":46},[50],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":51},"gerich.torsten@chl.lu",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55,57],{"name":56,"class":6},"PrimeVigilance",{"name":58,"class":59},"Data Investigation Company Europe (DICE)","UNKNOWN","100556987","phase-1-long-term-safety-trial-with-nvdx3-100556987",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":71,"type":72},15,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","An study evaluating the long-term safety of all patients previously treated with NVDX3.",[79,80],"Distal Radius Fractures","Degenerative Lumbar Spondylolisthesis","2024-09-01",{"date":83,"type":84},"2024-09-05","ACTUAL",{"date":86,"type":84},"2024-08-22",{"date":88,"type":72},"2036-03",{"name":5,"class":6},1]