[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460909":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":10,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ennovate® Complex",null,"All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU)",[13],"Device: posterior stabilization for the cervical spine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","posterior stabilization for the cervical spine","The Ennovate® Complex Spinal System is a posterior stabilization for the Complex and upper-thoracic spine. The implants are used for the posterior multisegmental correction and stabilization over all sections of the spine.",[9],[21],{"name":22,"affiliation":23,"role":24},"Mohd Hisam, Prof. Dr.","Hospital Universiti Kebangsaan Malaysia (HUKM)","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Sarah Mattes","CONTACT","+497461950","sarah.mattes@aesculap.de",{"name":32,"role":28,"phone":29,"phoneExt":10,"email":33},"Stefan Maenz","stefan.maenz@aesculap.de",[35,47],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":10,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"University Hospital Brno","SUSPENDED","Brno","62500","Czechia",{"type":42,"coordinates":43},"Point",[44,45],16.60796,49.19522,{"lat":45,"lon":44},{"facility":23,"status":48,"city":49,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"RECRUITING","Kuala Lumpur","Malaysia","MY",{"type":42,"coordinates":53},[54,55],101.68653,3.1412,{"lat":55,"lon":54},[58],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":63,"class":6},"Raylytic GmbH","100460909","post-market-clinical-follow-up-study-on-the-safety-and-performance-of-ennovate-complex-100460909",false,"NCT05281757","Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex","Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients","COSINE","Inclusion Criteria:\n\n* Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old\n* Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18\n* Patient's indication according to IFU\n* Patient is not pregnant\n\nExclusion Criteria:\n\n* Patient's clear unability or unwillingness to participate in follow-up examinations","ALL",{"count":74,"type":75},200,"ESTIMATED","OBSERVATIONAL","Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)",[79,80,81,82,83],"Hyperkyphosis","Hyperlordosis","Congenital Scoliosis","Neuromuscular Scoliosis","Idiopathic Scoliosis",[85],"upper-thoracic spine","2026-06-01",{"date":88,"type":89},"2026-06-02","ACTUAL",{"date":91,"type":89},"2022-02-18",{"date":93,"type":75},"2028-10",{"name":5,"class":6},2]