Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-16 @ 9:29 AM
Study NCT ID:
NCT06524492
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Device Sensitivity', 'timeFrame': 'Approximately 1 hour', 'description': 'Study device sensitivity will be calculated as TP / (TP + FN).'}, {'measure': 'Study Device Specificity', 'timeFrame': 'Approximately 1 hour', 'description': 'Study device specificity will be calculated as TN / (TN + FP)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device\n2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n3. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n4. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision\n\nExclusion criteria\n\n1. Presence of an interfering open wound or edema in the study device measurement area\n2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives\n3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired\n4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days\n5. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study'}, 'identificationModule': {'nctId': 'NCT06524492', 'briefTitle': 'Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhaeos, Inc.'}, 'officialTitle': 'Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device', 'orgStudyIdInfo': {'id': '2024-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FlowSense', 'description': 'This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.', 'interventionNames': ['Device: FlowSense']}], 'interventions': [{'name': 'FlowSense', 'type': 'DEVICE', 'description': 'This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.', 'armGroupLabels': ['FlowSense']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Marriott Water Street', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rhaeos, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Special Recreation Association', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhaeos, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}