[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419814":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":51,"collaborators":7,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":7,"maxAge":7,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":7,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Sophysa","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Didier Scavarda, Prof","La Timone Children's Hospital - Paediatrics Neurosurgery Department","PRINCIPAL_INVESTIGATOR",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Océane Amiotte, Engineering Degree","CONTACT","+33 381885382","oamiotte@sophysa.fr",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Huong Tra LE, Msc","+33 1 69 35 3500","tle@sophysa.com",[24,39],{"facility":25,"status":26,"city":27,"state":7,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"La Timone Children's Hospital","RECRUITING","Marseille","13385","France","FR",{"type":32,"coordinates":33},"Point",[34,35],5.38107,43.29695,{"lat":35,"lon":34},[38],{"name":10,"role":16,"phone":7,"phoneExt":7,"email":7},{"facility":40,"status":26,"city":41,"state":7,"zip":42,"country":29,"countryCode":30,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"La Pitié Salpétrière Hospital","Paris","75013",{"type":32,"coordinates":44},[45,46],2.3488,48.85341,{"lat":46,"lon":45},[49],{"name":50,"role":16,"phone":7,"phoneExt":7,"email":7},"Bertrand Mathon, MD",{"type":52,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100419814","safety-and-performance-of-the-polaris-24-adjustable-valve-system-in-hydrocephalus-patients-treatment-100419814",false,"NCT04746625","Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment","SAPPHYRE","Inclusion Criteria:\n\n* Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:\n\n  * Primo implant of a valve shunt-based derivation system, or as a\n  * Replacement of another valve -based shunt system, or\n  * Endoscopic ventriculostomy (EVT) failure\n* Patient having given his\u002Fher informed consent prior to inclusion in this study, as per local regulations\n\nExclusion Criteria:\n\n* Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body\n* Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system\n* Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system","ALL",{"count":62,"type":63},126,"ESTIMATED","5 Years","OBSERVATIONAL","The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.",[68],"Hydrocephalus",[68,70,71,72],"Adjustable valve","Polaris 24","Cerebrospinal fluid","2026-01-23",{"date":75,"type":76},"2026-01-27","ACTUAL",{"date":78,"type":76},"2021-06-04",{"date":80,"type":63},"2033-06",{"name":5,"class":6},2]