Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-04-11 @ 11:43 AM
Study NCT ID:
NCT05015751
Status:
COMPLETED
Last Update Posted:
2024-12-19
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of CSF Shunt Flow With Thermal Measurements A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@rhaeos.com', 'phone': '855-814-3569', 'title': 'Anna Somera', 'organization': 'Rhaeos, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '20 minutes', 'description': 'Patients were evaluated for adverse events during the use of the study device and for a period of 20 minutes thereafter.', 'eventGroups': [{'id': 'EG000', 'title': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.\n\nThermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Study Device Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.\n\nThermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14-day follow-up period', 'description': 'Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Study Device Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.\n\nThermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14-day follow-up period', 'description': 'Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.\n\nThermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.\n\nThermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'More than one Race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-18', 'size': 113468, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-13T09:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2021-08-10', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-17', 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Device Sensitivity', 'timeFrame': '14-day follow-up period', 'description': 'Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.'}, {'measure': 'Study Device Specificity', 'timeFrame': '14-day follow-up period', 'description': 'Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hydrocephalus']}, 'referencesModule': {'references': [{'pmid': '40522244', 'type': 'DERIVED', 'citation': 'Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.', 'detailedDescription': 'Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Existing ventriculoperitoneal CSF shunt\n* At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function\n* Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement\n* Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n* Available for follow-up for up to fourteen days\n* Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative.\n* Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision\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* Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed\n* Presence of an interfering open wound or edema over any portion of the shunt\n* Patient-reported history of adverse skin reactions to adhesives\n* Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n* Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject\n* Prior enrollment in this study (multiple enrollments of the same patient are disallowed)\n* Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study"}, 'identificationModule': {'nctId': 'NCT05015751', 'briefTitle': 'Assessment of CSF Shunt Flow With Thermal Measurements A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhaeos, Inc.'}, 'officialTitle': 'Assessment Of Flow In Cerebrospinal Fluid Shunts With A Wireless Thermal Anisotropy Measurement Device: Phase A', 'orgStudyIdInfo': {'id': '2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hydrocephalus Patients', 'description': 'Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.', 'interventionNames': ['Device: Thermal Anisotropy Measurement Device']}], 'interventions': [{'name': 'Thermal Anisotropy Measurement Device', 'type': 'DEVICE', 'otherNames': ['FlowSense'], 'description': 'A wireless device for non-invasively assessing CSF shunt flow.', 'armGroupLabels': ['Hydrocephalus Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital - Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Sandi Lam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhaeos, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}