[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04309487":3,"trial-entities:NCT04309487":87,"trial-summary:NCT04309487":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":15,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":52,"locations":55,"central_contacts":77,"overall_officials":83,"references":85,"see_also_links":86},"NCT04309487","Pro00041345","Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus","Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study","RECRUITING","2027-01","2026-05","2026-05-18","2020-01-24","University of South Florida","OTHER",null,"The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.",[18],"Hydrocephalus, Normal Pressure",[20,21],"Asymptomatic Normal Pressure Hydrocephalus","Ventriculoperitoneal Shunt","OBSERVATIONAL",[],{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","ShuntCheck","The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.",[30],[34,37],{"measure":35,"timeFrame":36},"Sensitivity of ShuntCheck compared to radionuclide shunt patency study","15 minutes",{"measure":38,"timeFrame":39},"Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study","60 Minutes",[],"ALL","40 Years",{"inclusion":44,"exclusion":47,"raw_text":51},[45,46],"Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.","Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as \"surrogates\" in this protocol) capable of providing valid, signed informed consent",[48,49,50],"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;","ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;","Presence of an interfering open wound or edema over any portion of the VP shunt.","Inclusion Criteria:\n\n* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.\n* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as \"surrogates\" in this protocol) 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 VP shunt.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":74},"University of South Florida Department of Neurological Surgery and Brain Repair","Tampa","Florida","33606","United States",[63,68,72],{"name":64,"role":65,"phone":66,"email":67},"Naomi Abel, MD","CONTACT","813 259-0904","nabel@usf.edu",{"name":69,"role":65,"phone":70,"email":71},"Konrad Bach, MD","813 259-8898","kbach@usf.edu",{"name":64,"role":73},"PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},27.94752,-82.45843,[78,79],{"name":64,"role":65,"phone":66,"email":67},{"name":80,"role":65,"phone":81,"email":82},"Thanh Tran, MD","813 8448544","tqtran@usf.edu",[84],{"name":64,"affiliation":13,"role":73},[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Normal pressure hydrocephalus",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an observational study, meaning researchers will observe and compare the results of two diagnostic tests. It plans to include 20 participants.","completed","ShuntCheck for Normal Pressure Hydrocephalus","This study is looking at how well a device called ShuntCheck works to find out if a shunt (a tube that drains fluid from the brain) is blocked in people with Normal Pressure Hydrocephalus (NPH). NPH is a condition where too much fluid builds up in the brain. ShuntCheck uses a special heat-based technology to check the shunt flow. Researchers want to see if ShuntCheck is as accurate as another test called radionuclide shunt patency testing. You might be able to join if you are 40 or older, have a VP shunt for NPH, and your doctor thinks your shunt might be blocked. The study will measure how good ShuntCheck is at correctly identifying blocked or unblocked shunts. The current status of this study is unclear, and it plans to enroll 20 participants.","The primary endpoints are measured at 15 minutes and 60 minutes after the ShuntCheck test.",133,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]