[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bioceramed\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,66,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100606742","evaluation-of-the-safety-and-performance-of-the-neocement-inject-p-a-prospective-observational-study-in-dental-area-100606742",false,"NCT07179510","Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area","NeoInjDent01","Inclusion Criteria:\n\n* Adult males or females (age \\> 18 years old);\n* Patients who are able to sign an informed consent form (for data collection);\n* Patients undergoing reconstructive dental surgery and indicated for the use of Neocement® Inject P;\n\nExclusion Criteria:\n\n* Patients who are unable to understand consent and the objectives of the study;\n* Signs of local or systemic acute\u002F active or chronic infections;\n* Metabolic affections;\n* Severe degenerative diseases, conditions in which general bone grafting is not advisable;\n* Implementation sites that allow product migration;\n* Conditions which require structural support in the skeletal system;\n* Conditions where the implantation site is unstable and not rigidly fixated;\n* Sensibility to the implantable materials;\n* Known hypersensitivity to the implant material.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","OBSERVATIONAL","This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.",[24],"Bone Augmentation",[26,27,28,29,30,31,32,33,34,35],"prospective observational clinical study","bone substitute","bone defects","real-world clinical data","safety","performance","medical device","reconstructive dental surgeries","Neocement® Inject P","calcium phosphates","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2025-10-06",{"date":44,"type":20},"2027-10",{"name":46,"class":47},"Bioceramed","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":65,"locationsCount":48},"100606741","evaluation-of-the-safety-and-performance-of-the-neobone-a-prospective-observational-study-in-dental-area-100606741","NCT07179497","Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area","NeoDent01","Inclusion Criteria:\n\n* Adult males or females (age \\> 18 years old);\n* Patients who are able to sign an informed consent form (for data collection);\n* Patients undergoing reconstructive dental surgery and indicated for the use of Neobone®;\n\nExclusion Criteria:\n\n* Patients who are unable to understand consent and the objectives of the study;\n* Signs of local or systemic acute\u002F active or chronic infections;\n* Metabolic affections;\n* Severe degenerative diseases, conditions in which general bone grafting is not advisable;\n* Implementation sites that allow product migration;\n* Conditions which require structural support in the skeletal system;\n* Conditions where the implantation site is unstable and not rigidly fixated;\n* Sensibility to the implantable materials;\n* Known hypersensitivity to the implant material.",{"count":19,"type":20},"This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.",[24],[26,27,28,60,61,29,30,31,32,33],"hydroxyapatite and beta tricalcium phosphate","Neobone®",{"date":39,"type":40},{"date":42,"type":40},{"date":44,"type":20},{"name":46,"class":47},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":48},"100590885","evaluation-of-the-safety-and-performance-of-the-neocement-inject-p-100590885","NCT06973239","Evaluation of the Safety and Performance of the Neocement® Inject P","Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Orthopaedic Area","Inclusion Criteria:\n\n* Adult males or females (age \\> 18 years old);\n* Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® Inject P;\n* Patients who are able to sign an informed consent form (for data collection)\n* Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;\n* Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;\n\nExclusion Criteria:\n\n* Patients who are unable to understand consent and the objectives of the study;\n* Signs of local or systemic acute\u002F active or chronic infections;\n* Metabolic affections;\n* Severe degenerative diseases, conditions in which general bone grafting is not advisable;\n* Implementation sites that allow product migration;\n* Conditions which require structural support in the skeletal system;\n* Conditions where the implantation site is unstable and not rigidly fixated;\n* Sensibility to the implantable materials;\n* Known hypersensitivity to the implant material.",{"count":74,"type":20},80,"This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017\u002F745.",[77,78],"Bone Defects","Orthopaedic Surgery (30 Minutes or Longer)",[34,26,32,80,28,29,81,35,82],"performance and safety","post-market","synthetic bone substitute",{"date":39,"type":40},{"date":85,"type":40},"2025-09-05",{"date":87,"type":20},"2027-06",{"name":46,"class":47},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":105,"locationsCount":48},"100590884","evaluation-of-the-safety-and-performance-of-the-neocement-100590884","NCT06973226","Evaluation of the Safety and Performance of the Neocement®","Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area","Neocement01","Inclusion Criteria:\n\n* Adult males or females (age \\> 18 years old);\n* Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement®;\n* Patients who are able to sign an informed consent form (for data collection)\n* Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;\n* Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;\n\nExclusion Criteria:\n\n* Patients who are unable to understand consent and the objectives of the study;\n* Signs of local or systemic acute\u002F active or chronic infections;\n* Metabolic affections;\n* Severe degenerative diseases, conditions in which general bone grafting is not advisable;\n* Implementation sites that allow product migration;\n* Conditions which require structural support in the skeletal system;\n* Conditions where the implantation site is unstable and not rigidly fixated;\n* Sensibility to the implantable materials;\n* Known hypersensitivity to the implant material.",{"count":74,"type":20},"This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017\u002F745.",[77,78],[101,26,32,80,28,29,81,35,82],"Neocement®",{"date":39,"type":40},{"date":85,"type":40},{"date":87,"type":20},{"name":46,"class":47},""]