Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 11:16 AM
Study NCT ID:
NCT05534659
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial Shunt revision rate', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the ratio of the total number of patients with at least one revision to the total number of patients included in this study'}, {'measure': 'Total Shunt revision rate', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the ratio of the total number of revisions to the total number of ventricular CSF shunt operations'}, {'measure': 'The cause of shunt revision', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the cause of the shunt malfunction warranting revision operation'}, {'measure': 'Type of the revision operation', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the detailed description of the revision operation'}, {'measure': 'Revision-free survival', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the interval between index operation and the initial revision'}], 'secondaryOutcomes': [{'measure': 'Shunt revision-free survival among different hydrocephalus etiologies', 'timeFrame': 'since the time of index operation until the initial revision or 2022/07/31', 'description': 'the individual interval between index operation and the initial revision among different hydrocephalus etiologies'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hydrocephalus', 'Programmable shunt', 'Long-term outcome'], 'conditions': ['Hydrocephalus', 'Ventriculoperitoneal Shunt Malfunction']}, 'referencesModule': {'references': [{'pmid': '28648796', 'type': 'BACKGROUND', 'citation': 'Li M, Wang H, Ouyang Y, Yin M, Yin X. Efficacy and safety of programmable shunt valves for hydrocephalus: A meta-analysis. Int J Surg. 2017 Aug;44:139-146. doi: 10.1016/j.ijsu.2017.06.078. Epub 2017 Jun 22.'}, {'pmid': '31174190', 'type': 'BACKGROUND', 'citation': 'Rinaldo L, Bhargav AG, Nesvick CL, Lanzino G, Elder BD. Effect of fixed-setting versus programmable valve on incidence of shunt revision after ventricular shunting for idiopathic normal pressure hydrocephalus. J Neurosurg. 2019 Jun 7;133(2):564-572. doi: 10.3171/2019.3.JNS183077. Print 2020 Aug 1.'}, {'pmid': '21508873', 'type': 'BACKGROUND', 'citation': 'Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.'}]}, 'descriptionModule': {'briefSummary': 'Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.', 'detailedDescription': "Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.\n\nThe investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients who received CSF ventricular shunting operations at Chang Gung Medical Foundation, Linkou Branch, a tertiary medical center in northern Taiwan, would be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01\\~2017/12/31\n\nExclusion Criteria:\n\n* Patients who received index ventricular CSF shunt at other hospitals,\n* Patients who received index ventricular CSF shunt before January 1st 2017,\n* Patients who were younger than 18'}, 'identificationModule': {'nctId': 'NCT05534659', 'briefTitle': 'Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt', 'orgStudyIdInfo': {'id': '202200775B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Programmable valve(PV) group', 'description': 'Adult patients with hydrocephalus who received programmable ventricular CSF shunts operation.', 'interventionNames': ['Device: Programmable valve']}, {'label': 'Non-programmable valve(NPV) group', 'description': 'Adult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation.', 'interventionNames': ['Device: Non-programmable valve']}], 'interventions': [{'name': 'Programmable valve', 'type': 'DEVICE', 'description': 'Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.', 'armGroupLabels': ['Programmable valve(PV) group']}, {'name': 'Non-programmable valve', 'type': 'DEVICE', 'description': 'Non-programmable valve used in the study was Medtronic CSF-flow control valve.', 'armGroupLabels': ['Non-programmable valve(NPV) group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ZHUO HAO Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}