[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436838":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":7,"maxAge":7,"enrollmentInfo":57,"targetDuration":7,"studyType":60,"phases":7,"briefSummary":61,"conditions":62,"keywords":7,"overallStatus":11,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"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},"UZ Gent","RECRUITING","Ghent","9000","Belgium","BE",{"type":17,"coordinates":18},"Point",[19,20],3.71667,51.05,{"lat":20,"lon":19},[23,28],{"name":24,"role":25,"phone":26,"phoneExt":7,"email":27},"Anne-Françoise Spinoit, MD","CONTACT","+32 9 332 21 11","info@uzgent.be",{"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},"Centre Hospitalier Lyon Sud","Pierre-Bénite","69495","France","FR",{"type":17,"coordinates":37},[38,39],4.82424,45.70359,{"lat":39,"lon":38},[42,46],{"name":43,"role":25,"phone":44,"phoneExt":7,"email":45},"Nicolas Morel Journel, MD","0 825 08 25 69","chu-lyon@chu-lyon.fr",{"name":43,"role":29,"phone":7,"phoneExt":7,"email":7},{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100436838","sebbin-silicone-gel-filled-testicular-implants-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":58,"type":59},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.",[63,64],"Complication","Prosthesis Durability","2024-10-30",{"date":67,"type":68},"2024-10-31","ACTUAL",{"date":70,"type":68},"2021-03-16",{"date":72,"type":59},"2035-09",{"name":5,"class":6},2]