[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436838":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":7,"maxAge":7,"enrollmentInfo":54,"targetDuration":7,"studyType":57,"phases":7,"briefSummary":58,"conditions":59,"keywords":7,"overallStatus":11,"whyStopped":7,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"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},"UZ Gent","RECRUITING","Ghent","9000","Belgium",{"type":16,"coordinates":17},"Point",[18,19],3.71667,51.05,{"lat":19,"lon":18},[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Anne-Françoise Spinoit, MD","CONTACT","+32 9 332 21 11","info@uzgent.be",{"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},"Centre Hospitalier Lyon Sud","Pierre-Bénite","69495","France",{"type":16,"coordinates":35},[36,37],4.82424,45.70359,{"lat":37,"lon":36},[40,44],{"name":41,"role":24,"phone":42,"phoneExt":7,"email":43},"Nicolas Morel Journel, MD","0 825 08 25 69","chu-lyon@chu-lyon.fr",{"name":41,"role":28,"phone":7,"phoneExt":7,"email":7},{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100436838",false,"NCT04968470","SEBBIN Silicone Gel-filled Testicular Implants","Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants","Inclusion Criteria:\n\n* The patient is an adult or a child at the time of implant placement with SEBBIN implant.\n* The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.\n* The patient has been informed of the study, has read the patient information letter and -provided oral consent.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac.\n* The patient was diagnosed with one of the following pathologies:\n\n  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n* The patient has a pathology that could delay healing.\n* Custom-designed implants are used for surgery.","ALL",{"count":55,"type":56},100,"ESTIMATED","OBSERVATIONAL","This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular 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.",[60,61],"Complication","Prosthesis Durability","2024-10-30",{"date":64,"type":65},"2024-10-31","ACTUAL",{"date":67,"type":65},"2021-03-16",{"date":69,"type":56},"2035-09",{"name":5,"class":6},2]