[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100363388":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":24,"armGroups":25,"interventions":31,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":68,"collaborators":71,"id":75,"slug":11,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":11,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Specificity of ShuntCheck test",null,"15 minutes",{"measure":14,"description":11,"timeFrame":12},"Negative Predictive Value of ShuntCheck test",[16,19],{"measure":17,"description":11,"timeFrame":18},"Specificity of performing ShuntCheck test twice","60 minutes",{"measure":20,"description":11,"timeFrame":18},"Negative Predictive Value of performing ShuntCheck test twice",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":22,"timePerspective":23,"maskingInfo":11},"COHORT","PROSPECTIVE","The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.",[26],{"label":27,"type":11,"description":28,"interventionNames":29},"ShuntCheck","Participants will be administered the ShuntCheck diagnostic test.",[30],"Diagnostic Test: ShuntCheck",[32],{"type":33,"name":27,"description":34,"armGroupLabels":35,"otherNames":11},"DIAGNOSTIC_TEST","The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.",[27],[37],{"name":38,"affiliation":5,"role":39},"Naomi Abel, MD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":11,"email":44},"CONTACT","813 259-0904","nabel@usf.edu",{"name":46,"role":42,"phone":47,"phoneExt":11,"email":48},"Rachel Karlnoski, MD","813 974 8558","Karlnosk@usf.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of South Florida Department of Neurological Surgery and Brain Repair","RECRUITING","Tampa","Florida","33606","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-82.45843,27.94752,{"lat":62,"lon":61},[65,67],{"name":38,"role":42,"phone":43,"phoneExt":11,"email":66},"nabel@health.usf.edu",{"name":38,"role":39,"phone":11,"phoneExt":11,"email":11},{"type":39,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Naomi Abel","Assistant Professor, College of Medicine Neurosurgery",[72],{"name":73,"class":74},"NeuroDx Development","INDUSTRY","100363388",false,"NCT04011566","Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus","Inclusion Criteria:\n\n* Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.\n* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.\n\nExclusion Criteria:\n\n* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;\n* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;\n* Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.","ALL","40 Years",{"count":83,"type":84},50,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.",[88],"Hydrocephalus, Normal Pressure",[90,91],"Asymptomatic Normal Pressure Hydrocephalus","Ventriculoperitoneal Shunt","2026-05-14",{"date":94,"type":95},"2026-05-19","ACTUAL",{"date":97,"type":95},"2019-06-11",{"date":99,"type":84},"2026-11",{"name":5,"class":6},1]