[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sophysa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":19,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":17,"type":18},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.",[23],"Hydrocephalus",[23,25,26,27],"Adjustable valve","Polaris 24","Cerebrospinal fluid","RECRUITING","2026-01-23",{"date":31,"type":32},"2026-01-27","ACTUAL",{"date":34,"type":32},"2021-06-04",{"date":36,"type":18},"2033-06",{"name":38,"class":39},"Sophysa","INDUSTRY",2,""]