Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-07 @ 5:14 PM
Study NCT ID:
NCT02200458
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Near-infrared Software Performance Study
Sponsor:
Organization:
Raw JSON
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II (7-13) White/fair; blond/red hair; blue/green/hazel eyes - Usually burns/tans minimally. III (14-20) Cream white; fair with any hair/eye color; quite common - Sometimes mild burn/uniformly. IV (21-27) Olive to moderate brown; typical Mediterranean skin tone - Rarely burns/always tans well. V (28-34) Dark brown; South Asian skin types - Very rarely burns/tans very easily. VI (35+) Deeply pigmented dark brown to black - Never burns/tans very easily', 'unitOfMeasure': 'Points', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2014-07-21', 'resultsFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-03', 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants for Whom Successful Visualization of Vasculature Was Achieved', 'timeFrame': 'One day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vascular Access Complication']}, 'descriptionModule': {'briefSummary': 'This study will look at the performance capabilities of software for VeinViewer.', 'detailedDescription': 'This study will look at the performance capabilities of future software for VeinViewer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be 18 years of age or older\n2. Must be considered to be in overall good health by investigator\n3. Must pass all prescreening questions\n4. Must be able to read and understand English\n\nExclusion Criteria:\n\n1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.\n2. IV cannulation in the arms or hands in the previous 4 weeks.'}, 'identificationModule': {'nctId': 'NCT02200458', 'briefTitle': 'Near-infrared Software Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Christie Medical Holdings, Inc.'}, 'officialTitle': 'Near-Infrared Software Performance Study', 'orgStudyIdInfo': {'id': 'CP1019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VeinViewer', 'description': 'Vascular imaging technology will be used to visualize peripheral vasculature.', 'interventionNames': ['Device: VeinViewer']}], 'interventions': [{'name': 'VeinViewer', 'type': 'DEVICE', 'description': 'Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.', 'armGroupLabels': ['VeinViewer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Christie Medical Holdings, Inc.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Gregory Schears, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christie Medical Holdings, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christie Medical Holdings, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}