Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02119351
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-03', 'releaseDate': '2015-05-18'}, {'resetDate': '2017-08-02', 'releaseDate': '2017-04-24'}], 'estimatedResultsFirstSubmitDate': '2015-05-18'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical acceptability of PIVC insertion', 'timeFrame': 'Clinicians will provide the rating immediately after performing the insertion', 'description': 'Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion.'}, {'measure': 'Frequency of blood leakage', 'timeFrame': 'Clinicians will report if blood leakage occurred immediately after the catheter insertion', 'description': 'Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.'}, {'measure': 'Eliminating risk of blood exposure', 'timeFrame': 'Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion', 'description': "Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process."}], 'secondaryOutcomes': [{'measure': 'Insertion success', 'timeFrame': 'Clinicians will report if the insertion was successful immediately after performing insertion', 'description': 'Demonstrate the insertion success rate of the ViaValve™ I.V. Catheter is non-inferior to the control PIVC. Insertion success defined as a catheter confirmed successfully placed within the selected vessel in 3 or fewer venipuncture attempts.'}, {'measure': 'Elimination of digital compression', 'timeFrame': 'Clinicians will provide the rating immediately after performing the insertion', 'description': "Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in eliminating the clinician's need to use digital compression during the insertion process. Clinicians will agree or disagree the device eliminates the need for digital compression after each PIVC insertion."}, {'measure': 'Ease of Use', 'timeFrame': 'Clinicians will provide the rating immediately after performing the insertion', 'description': 'Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in seven measures of ease of use. Clinicians will agree or disagree with seven statements regarding ease of use/clinical utility.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral intravenous catheters', 'blood exposure', 'blood control', 'IV catheter insertion'], 'conditions': ['Peripheral Intravenous Catheter']}, 'descriptionModule': {'briefSummary': 'The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.\n* Willing and able to sign an Informed Consent (patient or legally authorized representative).\n\nExclusion Criteria:\n\n* Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.\n* Fluid to be infused is not appropriate for peripheral intravenous catheters.'}, 'identificationModule': {'nctId': 'NCT02119351', 'acronym': 'ViaValve-001', 'briefTitle': 'A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smiths Medical, ASD, Inc.'}, 'officialTitle': 'A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter', 'orgStudyIdInfo': {'id': 'ViaValve Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ViaValve™ Safety IV Catheter', 'description': 'Insertion of the ViaValve™ Safety IV Catheter', 'interventionNames': ['Device: ViaValve™ Safety IV Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ProtectIV® Plus Safety IV Catheter', 'description': 'Insertion of the ProtectIV® Plus Safety IV Catheter', 'interventionNames': ['Device: ProtectIV® Plus Safety IV Catheter']}], 'interventions': [{'name': 'ViaValve™ Safety IV Catheter', 'type': 'DEVICE', 'description': 'Safety peripheral IV catheter with a blood control feature', 'armGroupLabels': ['ViaValve™ Safety IV Catheter']}, {'name': 'ProtectIV® Plus Safety IV Catheter', 'type': 'DEVICE', 'description': 'Safety peripheral IV catheter with no blood control feature', 'armGroupLabels': ['ProtectIV® Plus Safety IV Catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Andrew McRae, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of Calgary and Alberta Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smiths Medical, ASD, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-18', 'type': 'RELEASE'}, {'date': '2015-06-03', 'type': 'RESET'}, {'date': '2017-04-24', 'type': 'RELEASE'}, {'date': '2017-08-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Smiths Medical, ASD, Inc.'}}}}