Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-28 @ 1:55 PM
Study NCT ID:
NCT01020461
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2009-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Accuvein in Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'whyStopped': 'Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath"', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2009-11-22', 'studyFirstSubmitQcDate': '2009-11-23', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to successful blood sampling or to successful placement of IV catheter', 'timeFrame': 'one hour'}], 'secondaryOutcomes': [{'measure': 'Number of attempts required', 'timeFrame': 'Immediately after attempts'}, {'measure': 'Pain', 'timeFrame': 'Immediately after attempts'}, {'measure': 'Increases in the ease and efficiency of venous cannulation perceived by the operator)', 'timeFrame': 'Immediately after attempts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Catheterization']}, 'referencesModule': {'references': [{'pmid': '25176152', 'type': 'DERIVED', 'citation': 'Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults requiring a venous blood sampling or the placement of a venous peripheral catheter\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01020461', 'briefTitle': 'Evaluation of Accuvein in Adult Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients', 'orgStudyIdInfo': {'id': '2009/43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venous blood sampling', 'description': 'To use Accuvein to improve the effectiveness of venous blood sampling', 'interventionNames': ['Device: Accuvein']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral IV catheter placement', 'description': 'To use Accuvein to improve the effectiveness of placing peripheral IV catheter', 'interventionNames': ['Device: Accuvein']}], 'interventions': [{'name': 'Accuvein', 'type': 'DEVICE', 'description': 'Accuvein will be used to facilitate venous blood sampling', 'armGroupLabels': ['Venous blood sampling']}, {'name': 'Accuvein', 'type': 'DEVICE', 'description': 'Accuvein will be used to facilitate peripheral IV catheter placement', 'armGroupLabels': ['Peripheral IV catheter placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}