Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-02 @ 3:33 AM
Study NCT ID:
NCT01937195
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nanderson@evanhospital.com', 'phone': '570-222-2000', 'title': 'Norman R. Anderson', 'organization': 'Evangelical Community Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During enrollment from April 2013 through June 2014.', 'description': 'IV complications are anticipated events during conventional IV therapy and occur about 47% of the time.', 'eventGroups': [{'id': 'EG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.', 'otherNumAtRisk': 95, 'otherNumAffected': 17, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '91.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure', 'description': 'The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients requiring IV therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complications of Peripheral IV Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '27.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatient units requiring IV therapy.'}, {'type': 'SECONDARY', 'title': 'Completion of IV Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients requiring IV therapy.'}, {'type': 'SECONDARY', 'title': 'Catheter Dwell Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '49.1', 'upperLimit': '66.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline at catheter insertion in the first 3-15 minutes after procedure', 'description': 'Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients requiring IV therapy'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Phlebitis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Infiltration', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Leaking', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Dislodgement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, and up to catheter removal expected to be no more than 7 days post placement', 'description': 'Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients requiring IV therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At catheter removal, which is expected to be up to 7 days post placement', 'description': 'Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients requiring IV therapy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AccuCath Intravenous Catheter Device', 'description': 'AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Inpatients requiring IV therapy during hospital admission of \\> 24 hours.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2013-04-15', 'resultsFirstSubmitDate': '2015-05-16', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-09', 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt', 'timeFrame': 'Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure', 'description': 'The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Complications of Peripheral IV Therapy', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).'}, {'measure': 'Completion of IV Therapy', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).'}, {'measure': 'Catheter Dwell Time', 'timeFrame': 'Study exit/at catheter removal expected to be up to 7 days post placement', 'description': 'Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.'}, {'measure': 'Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion', 'timeFrame': 'Baseline at catheter insertion in the first 3-15 minutes after procedure', 'description': 'Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.'}, {'measure': 'Number of Participants Experiencing Adverse Events', 'timeFrame': 'baseline, and up to catheter removal expected to be no more than 7 days post placement', 'description': 'Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.'}, {'measure': 'Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal', 'timeFrame': 'At catheter removal, which is expected to be up to 7 days post placement', 'description': 'Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IV Catheter comparison', 'AccuCath versus Conventional IV Catheters', 'IV Catheter Study', 'IV Catheter User Preference Comparison', 'First Attempt Success Rate for IV Catheters', 'AccuCath Device Performance', 'Complication Rates for IV Catheters', 'Average Dwell Time for IV Catheters', 'Patient Satisfaction with IV Catheters', 'Clinician Satisfaction with AccuCath Device Performance'], 'conditions': ['Vascular Access Complication']}, 'referencesModule': {'references': [{'pmid': '27379678', 'type': 'RESULT', 'citation': 'Anderson NR. Influencing Patient Satisfaction Scores: Prospective One-Arm Study of a Novel Intravenous Catheter System With Retractable Coiled-Tip Guidewire Compared With Published Literature for Conventional Peripheral Intravenous Catheters. J Infus Nurs. 2016 Jul-Aug;39(4):201-9. doi: 10.1097/NAN.0000000000000173.'}]}, 'descriptionModule': {'briefSummary': 'The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.', 'detailedDescription': 'Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, age \\> or equal to 18 years or \\< or equal to 89 years old;\n2. Capable and willing to give informed consent;\n3. English speaking;\n4. Acceptable candidate for an elective, non-emergent PIV as determined by ordering physician;\n5. Admitted to study inpatient unit.\n\nExclusion Criteria:\n\n1. Male or female, \\< 18 years old or \\> 89 years old;\n2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);\n3. Previous venous grafts or surgery at the target vessel access site;\n4. Currently involved in other investigational clinical trials (unless permission is granted by other study PI);\n5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating."}, 'identificationModule': {'nctId': 'NCT01937195', 'briefTitle': 'AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team', 'orgStudyIdInfo': {'id': 'VPW-STP-00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AccuCath Intravenous Catheter System', 'description': 'AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal.', 'interventionNames': ['Device: AccuCath Intravenous Catheter System']}], 'interventions': [{'name': 'AccuCath Intravenous Catheter System', 'type': 'DEVICE', 'description': 'AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.', 'armGroupLabels': ['AccuCath Intravenous Catheter System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17837', 'city': 'Lewisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Evangelical Community Hospital', 'geoPoint': {'lat': 40.96453, 'lon': -76.88441}}], 'overallOfficials': [{'name': 'Norman R Anderson, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Evangelical Community Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}