Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-29 @ 12:06 PM
Study NCT ID:
NCT04011566
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity of ShuntCheck test', 'timeFrame': '15 minutes'}, {'measure': 'Negative Predictive Value of ShuntCheck test', 'timeFrame': '15 minutes'}], 'secondaryOutcomes': [{'measure': 'Specificity of performing ShuntCheck test twice', 'timeFrame': '60 minutes'}, {'measure': 'Negative Predictive Value of performing ShuntCheck test twice', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asymptomatic Normal Pressure Hydrocephalus', 'Ventriculoperitoneal Shunt'], 'conditions': ['Hydrocephalus, Normal Pressure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT04011566', 'briefTitle': 'Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus', 'orgStudyIdInfo': {'id': 'Pro00040697'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ShuntCheck', 'description': 'Participants will be administered the ShuntCheck diagnostic test.', 'interventionNames': ['Diagnostic Test: ShuntCheck']}], 'interventions': [{'name': 'ShuntCheck', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.', 'armGroupLabels': ['ShuntCheck']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Naomi Abel, MD', 'role': 'CONTACT', 'email': 'nabel@health.usf.edu', 'phone': '813-259-0904'}, {'name': 'Naomi Abel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida Department of Neurological Surgery and Brain Repair', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Naomi Abel, MD', 'role': 'CONTACT', 'email': 'nabel@usf.edu', 'phone': '813 259-0904'}, {'name': 'Rachel Karlnoski, MD', 'role': 'CONTACT', 'email': 'Karlnosk@usf.edu', 'phone': '813 974 8558'}], 'overallOfficials': [{'name': 'Naomi Abel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'individual participant data that underlies the results reported after deidentification and statistical analysis will be shared following publication for 5 years with researchers who provide a methodologically sound proposal', 'ipdSharing': 'YES', 'description': 'individual participant data that underlies the results reported after deidentification and statistical analysis will be shared following publication for 5 years with researchers who provide a methodologically sound proposal', 'accessCriteria': 'data use agreement required and methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroDx Development', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, College of Medicine Neurosurgery', 'investigatorFullName': 'Naomi Abel', 'investigatorAffiliation': 'University of South Florida'}}}}