[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444077":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":7,"locations":8,"responsibleParty":47,"collaborators":7,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":7,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":7,"enrollmentInfo":58,"targetDuration":7,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":7,"overallStatus":11,"whyStopped":7,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Groupe SEBBIN","INDUSTRY",null,[9,30],{"facility":10,"status":11,"city":12,"state":7,"zip":13,"country":14,"countryCode":15,"cosmosGeoPoint":16,"geoPoint":21,"contacts":22},"Istituto Estetico Italiano","RECRUITING","Roma","00193","Italy","IT",{"type":17,"coordinates":18},"Point",[19,20],11.10642,44.99364,{"lat":20,"lon":19},[23,28],{"name":24,"role":25,"phone":26,"phoneExt":7,"email":27},"Valerio Badiali, MD","CONTACT","+39 393 968 3014","info@valeriobadiali.com",{"name":24,"role":29,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"facility":31,"status":11,"city":32,"state":7,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":40,"contacts":41},"Medical Clinic \"Essential Aesthetics\"","The Hague","2582","Netherlands","NL",{"type":17,"coordinates":37},[38,39],4.29861,52.07667,{"lat":39,"lon":38},[42,46],{"name":43,"role":25,"phone":44,"phoneExt":7,"email":45},"Philippe Levan, MD","925.855.1773","info@essentialaesthetics.net",{"name":43,"role":29,"phone":7,"phoneExt":7,"email":7},{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100444077","sebbin-round-anatomical-and-biconvex-gluteal-implants-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":59,"type":60},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.",[64,65],"Complication","Prosthesis Durability","2024-10-30",{"date":68,"type":69},"2024-10-31","ACTUAL",{"date":71,"type":69},"2021-11-20",{"date":73,"type":60},"2035-03",{"name":5,"class":6},2]