Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-02 @ 12:44 AM
Study NCT ID:
NCT01453335
Status:
COMPLETED
Last Update Posted:
2011-12-23
First Post:
2011-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percentage Venous Options in Pediatrics & Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2011-08-23', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Veins Identified with VeinViewer will be greater than those identified by sight or sight & palpation', 'timeFrame': 'Immediately after assessment-Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Veins', 'Catheter Segments', 'Vascular Access', 'VeinViewer Vision'], 'conditions': ['Veins']}, 'descriptionModule': {'briefSummary': 'VeinViewer® Vision will significantly increase the number of peripheral intravenous catheter access targets perceived by clinicians with experience in intravenous cannulation when compared to the number of access targets that these clinicians are able to visualize unaided or to palpate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric \\& Adult patients presenting at the Emergency Department that do not have an acute or critical medical illness or injury that required immediate evaluation and/or treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pediatric arm\n\nInclusion Criteria:\n\n* Age 17 years of age or younger,\n* Intact skin, without rash,irritation, scarring, open abrasion or other injury in these sites.\n* Parent or guardian is English speaking\n* Pediatric patients 8 years older will be asked to provide assent\n* Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.\n\nExclusion Criteria:\n\n* 18 years of age or older\n* No intact upper extremities\n* Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.\n* Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.\n\nAdult arm:\n\nInclusion Criteria:\n\n* Age 18 years or older,\n* At least one intact upper extremity (intact from the base knuckle to the shoulder)\n* Intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury in these sites.\n* Participant does not have an acute or critical medical illness or injury requiring immediate evaluation and/or treatment.\n\nExclusion Criteria\n\n* Younger than 18 years of age\n* No intact upper extremities\n* The participant does not have intact skin on the dorsum of the hand, the ventral forearm, and antecubital fossa, without rash, irritation, scarring, open abrasion or other injury preventing appropriate evaluation of these sites.\n* Non-English speaking participant.\n* Patient has had current or recent (within 6 months) venous access in the arm that will be evaluated.\n* Acute or critical illness or injury requiring immediate or urgent evaluation and treatment.'}, 'identificationModule': {'nctId': 'NCT01453335', 'briefTitle': 'Percentage Venous Options in Pediatrics & Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Christie Medical Holdings, Inc.'}, 'officialTitle': 'Utilizing a Near Infrared Vein Visualization Device To Increase Peripheral Intravenous Access Targets in Pediatric & Adult Patients (% Venous Options)', 'orgStudyIdInfo': {'id': 'CP1001'}}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "HASBRO Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Bruce M Becker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hasbro Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christie Medical Holdings, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}