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