[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444077":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":7,"locations":8,"responsibleParty":45,"collaborators":7,"id":47,"slug":7,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":7,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":7,"enrollmentInfo":55,"targetDuration":7,"studyType":58,"phases":7,"briefSummary":59,"conditions":60,"keywords":7,"overallStatus":11,"whyStopped":7,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Groupe SEBBIN","INDUSTRY",null,[9,29],{"facility":10,"status":11,"city":12,"state":7,"zip":13,"country":14,"cosmosGeoPoint":15,"geoPoint":20,"contacts":21},"Istituto Estetico Italiano","RECRUITING","Roma","00193","Italy",{"type":16,"coordinates":17},"Point",[18,19],11.10642,44.99364,{"lat":19,"lon":18},[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Valerio Badiali, MD","CONTACT","+39 393 968 3014","info@valeriobadiali.com",{"name":23,"role":28,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"facility":30,"status":11,"city":31,"state":7,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":38,"contacts":39},"Medical Clinic \"Essential Aesthetics\"","The Hague","2582","Netherlands",{"type":16,"coordinates":35},[36,37],4.29861,52.07667,{"lat":37,"lon":36},[40,44],{"name":41,"role":24,"phone":42,"phoneExt":7,"email":43},"Philippe Levan, MD","925.855.1773","info@essentialaesthetics.net",{"name":41,"role":28,"phone":7,"phoneExt":7,"email":7},{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100444077",false,"NCT05062733","SEBBIN Round, Anatomical and Biconvex Gluteal Implants","Prospective Observational Study About SEBBIN Gluteal Implants","Inclusion Criteria:\n\n* The patient is a man or a woman ≥ 18 years old at the time of inclusion.\n* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision\n* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.\n\nExclusion Criteria:\n\n* Patient implanted with silicone implants somewhere else in the body.\n* Patient candidate for implantation with custom-designed implants.\n* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.","ALL","18 Years",{"count":56,"type":57},60,"ESTIMATED","OBSERVATIONAL","This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.",[61,62],"Complication","Prosthesis Durability","2024-10-30",{"date":65,"type":66},"2024-10-31","ACTUAL",{"date":68,"type":66},"2021-11-20",{"date":70,"type":57},"2035-03",{"name":5,"class":6},2]