Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT00914069
Status:
TERMINATED
Last Update Posted:
2017-04-13
First Post:
2009-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gina.Gilbert@crbard.com', 'phone': '407-489-0835', 'title': 'Gina Gilbert', 'organization': 'Bard Access Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'The Principal Investigators may publish or present the study results with prior consent of the Sponsor, but will not disclose confidential information. Prior to submission by a Principal Investigator for publication or presentation, the Sponsor will be provided with the opportunity to review the submission for confidential information and accuracy.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature', 'otherNumAtRisk': 84, 'otherNumAffected': 1, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device', 'otherNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor Vasular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'OG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Summary of Major Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'OG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-PIV placement until catheter removal (usually within 4 days)', 'description': 'Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Required to Obtain Access', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'OG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A secured flushed IV will be indicative of a successful PIV placement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Second Stick Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'OG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A secured flushed IV will be indicative of a successful PIV placement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow Module because not all participants required a second attempt at catheter placement.'}, {'type': 'SECONDARY', 'title': 'Summary of Minor Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'OG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-PIV placement until catheter removal (usually within 4 days)', 'description': 'Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'FG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Prior to assignment to groups, two subjects withdrew from the study. Also prior to group assignment, one subject did not have a consent form and was excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RIVS Vascular Access', 'description': 'RIVS vascular access\n\nRIVS vascular access: Access to peripheral vasculature'}, {'id': 'BG001', 'title': 'Conventional Vascular Access', 'description': 'Conventional vascular access\n\nConventional vascular access: Vascular access using conventional venous access device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.1', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex data were missing for two (2) subjects.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'whyStopped': 'Funding Stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2009-06-01', 'resultsFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-02', 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.'}, {'measure': 'Summary of Major Complications', 'timeFrame': 'Post-PIV placement until catheter removal (usually within 4 days)', 'description': 'Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.'}], 'secondaryOutcomes': [{'measure': 'Time Required to Obtain Access', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A secured flushed IV will be indicative of a successful PIV placement.'}, {'measure': 'Second Stick Success Rate', 'timeFrame': 'An access attempt usually ranges from 0 to 45 minutes in duration.', 'description': 'A secured flushed IV will be indicative of a successful PIV placement.'}, {'measure': 'Summary of Minor Complications', 'timeFrame': 'Post-PIV placement until catheter removal (usually within 4 days)', 'description': 'Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vascular Access Complication']}, 'descriptionModule': {'briefSummary': 'The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.', 'detailedDescription': 'The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years\n* Requires peripheral IV as determined by examining physician\n* Requires the IV when a study nurse or resident is available\n* Able to sign an informed consent\n\nExclusion Criteria\n\n* Active systemic or cutaneous infection or inflammation;\n* Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;\n* Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \\< 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);\n* Currently involved in any other investigational clinical trials;\n* Previous vascular grafts or surgery at the target vessel access site;\n* Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;\n* Central line available\n* Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)"}, 'identificationModule': {'nctId': 'NCT00914069', 'briefTitle': 'Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial', 'orgStudyIdInfo': {'id': '62009123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIVS vascular access', 'description': 'RIVS vascular access', 'interventionNames': ['Device: RIVS vascular access']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional vascular access', 'description': 'Conventional vascular access', 'interventionNames': ['Device: Conventional vascular access']}], 'interventions': [{'name': 'RIVS vascular access', 'type': 'DEVICE', 'description': 'Access to peripheral vasculature', 'armGroupLabels': ['RIVS vascular access']}, {'name': 'Conventional vascular access', 'type': 'DEVICE', 'description': 'Vascular access using conventional venous access device', 'armGroupLabels': ['Conventional vascular access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Washington Outpatient Surgery Center', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "St. Vincent's Medical Center", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jeffrey S Stuart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Outpatient Surgery Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}