Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT01232933
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2010-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time', 'timeFrame': 'participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation'}], 'secondaryOutcomes': [{'measure': 'The VPS will provide a blue bullseye indicator 80-90% of the time', 'timeFrame': 'participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PICC'], 'conditions': ['Any Condition Requiring a PICC Placement']}, 'descriptionModule': {'briefSummary': 'Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with a PICC placement order\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Abnormal ECG\n* Anatomic irregularities or history that would prevent proper placement\n* Subject does not consent to photography, release of data and x-ray confirmation\n* Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release'}, 'identificationModule': {'nctId': 'NCT01232933', 'briefTitle': 'Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'VasoNova, Inc.'}, 'officialTitle': 'Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy', 'orgStudyIdInfo': {'id': 'TP-0120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VPS System', 'description': 'Use of navigational VPS system to place catheter', 'interventionNames': ['Device: VPS System']}], 'interventions': [{'name': 'VPS System', 'type': 'DEVICE', 'description': 'Use of the navigational VPS system during catheter placement', 'armGroupLabels': ['VPS System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VasoNova, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kim Tompkins, VP Regulatory and Clinical Research', 'oldOrganization': 'VasoNova, Inc.'}}}}