Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-01 @ 10:27 AM
Study NCT ID:
NCT00651950
Status:
WITHDRAWN
Last Update Posted:
2012-06-05
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn due to lack of enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-04', 'studyFirstSubmitDate': '2008-03-31', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard deviation of error between operator-measured flow measurements and actual flow measurements.', 'timeFrame': 'Daily and weekly'}], 'secondaryOutcomes': [{'measure': 'Flow measurement accuracy vs. the number of times the measurement is conducted.', 'timeFrame': 'Daily, weekly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydrocephalus', 'shunt dysfunction', 'shunt flow'], 'conditions': ['Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.\n\nThe study participants will align the flowmeter probe with a flow sensor hidden under a thick saline pad that simulates skin. A hidden pump will provide a known flow through the flow sensor as the participants make their measurements. Each participant will repeat these measurements over a period of weeks, and the data will tell whether operator skill influences flow measurement accuracy.', 'detailedDescription': "The study hypothesis is that a transcutaneously powered ultrasonic flow sensor for hydrocephalic shunts can be repeatedly and accurately read by medical personnel ranging from nurses to senior neurosurgeons.\n\nThe test will involve a prototype implantable hydrocephalic shunt flow sensor and readout electronics. The readout electronics use a pickup coil to transcutaneously operate the sensor once the coil is aligned with sensor's inductive coupling coils.\n\nDuring the test, the shunt flow sensor will be hidden under a thick saline gel pad whose thickness approximates the skin thickness of an older pediatric patient. A syringe pump will provide a known flow rate through tubing connected to the sensor, but the study participants will not know the pump flow setting.\n\nThree neurosurgeons and six floor nurses will perform this study. Each will use the Transonic flowmeter readout to align the pickup coils of the flowmeter with the hidden sensor to make flow measurements.\n\nEach participant will repeat this measurement multiple times over non-consecutive days.\n\nThe recorded data will quantify measurement accuracy and repeatability between different operators, and will determine whether operator skill influences flow measurement accuracy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Three neurosurgeons and six nurses', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neurosurgeon\n* nurse\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00651950', 'briefTitle': 'Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transonic Systems Inc.'}, 'officialTitle': 'A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability', 'orgStudyIdInfo': {'id': 'TSI-G-HYDRO-1C-H'}, 'secondaryIdInfos': [{'id': '2R44NS049680-02', 'link': 'https://reporter.nih.gov/quickSearch/2R44NS049680-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operator Dependence'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Cornelis J Drost, BS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Transonic Systems Inc.'}, {'name': 'Bruce A Kaufman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital and Health System Foundation, Wisconsin"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transonic Systems Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}