[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419814":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":50,"collaborators":7,"id":52,"slug":7,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":7,"maxAge":7,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"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",[24,38],{"facility":25,"status":26,"city":27,"state":7,"zip":28,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"La Timone Children's Hospital","RECRUITING","Marseille","13385","France",{"type":31,"coordinates":32},"Point",[33,34],5.38107,43.29695,{"lat":34,"lon":33},[37],{"name":10,"role":16,"phone":7,"phoneExt":7,"email":7},{"facility":39,"status":26,"city":40,"state":7,"zip":41,"country":29,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"La Pitié Salpétrière Hospital","Paris","75013",{"type":31,"coordinates":43},[44,45],2.3488,48.85341,{"lat":45,"lon":44},[48],{"name":49,"role":16,"phone":7,"phoneExt":7,"email":7},"Bertrand Mathon, MD",{"type":51,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":60,"type":61},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.",[66],"Hydrocephalus",[66,68,69,70],"Adjustable valve","Polaris 24","Cerebrospinal fluid","2026-01-23",{"date":73,"type":74},"2026-01-27","ACTUAL",{"date":76,"type":74},"2021-06-04",{"date":78,"type":61},"2033-06",{"name":5,"class":6},2]