[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553604":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic third ventriculostomy (ETV) group","EXPERIMENTAL","The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH).",[13],"Procedure: Endoscopic third ventriculostomy (ETV)",{"label":15,"type":6,"description":16,"interventionNames":17},"Ventriculoperitoneal shunt (VPS) group","The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH.",[18],"Procedure: Ventriculoperitoneal shunt (VPS)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic third ventriculostomy (ETV)","The procedure is performed using an endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent). The intervention is carried out under general anesthesia, with the procedure typically lasting around 60 minutes.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Ventriculoperitoneal shunt (VPS)","The procedure entails the insertion of a catheter into both the ventricular system and the peritoneal cavity, connected to a programmable valve that regulates cerebrospinal fluid flow. The choice of programmable valve (Codman Hakim or Codman Certas Programmable Valves, Integra, Plainsboro, USA; Strata valve, Medtronic, Minneapolis, USA; Sophysa, Orsay, France; Miethke proGAV, Aesculap, Tuttlingen, Germany) is at the surgeon's discretion. The preoperative valve setting is preset to a pressure level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes.",[15],[31],{"name":32,"affiliation":33,"role":34},"Florian Marc Ebel, Dr. med.","Department of Neurosurgery, University Hospital of Basel","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+41 61 32 84296","florianmarc.ebel@usb.ch",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Raphael Guzman, Prof. Dr. med.","+41 61 32 87522","raphael.guzman@usb.ch",[45],{"facility":33,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Basel","4031","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],7.57327,47.55839,{"lat":55,"lon":54},[58,59,60],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Jehuda Soleman, Prof. Dr. med.","SUB_INVESTIGATOR",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100553604","endoscopic-third-ventriculostomy-vs-ventriculoperitoneal-shunt-in-idiopathic-normal-pressure-hydrocephalus-endovest-100553604",false,"NCT06488248","Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)","Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial","Inclusion Criteria:\n\n* \\>40 years of age\n* Symptom duration ≥3 months, \\\u003C24 months\n* No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus\n* MUST show gait\u002Fbalance disturbance, PLUS cognition impairment AND\u002FOR urinary dysfunction.\n* Ventricular enlargement (Evans Index \\> 0.3) not attributable to cerebral atrophy or congenital enlargement\n* No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test\n* Opening pressure (on lateral decubitus): \\\u003C24cmH2O\n* Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF\n\nExclusion Criteria:\n\n* ≤40 years of age\n* No informed consent\n* Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms.\n* Previous cranial neurosurgical interventions\n* Other associated dementia syndromes\n* Incapacity to walk\n* Pregnancy and breastfeeding women","ALL","40 Years",{"count":75,"type":76},150,"ESTIMATED","INTERVENTIONAL",[79],"NA","The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.",[82],"Idiopathic Normal Pressure Hydrocephalus (INPH)",[84,85,22,27],"Surgical treatment","Neurosurgery","2025-01-31",{"date":88,"type":89},"2025-02-03","ACTUAL",{"date":91,"type":89},"2025-01-17",{"date":93,"type":76},"2028-07-01",{"name":5,"class":6},1]