A Comprehensive Look at Vascular Access

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01638065
First received: July 9, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.


Condition
Vascular Access

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Comprehensive Look at Vascular Access: Utilizing a Near Infrared Vein Visualization Device For Vascular Access Planning, Attempts, and Post Access

Further study details as provided by Christie Medical Holdings, Inc.:

Primary Outcome Measures:
  • The primary endpoint will be total number of attempts for successful cannulation. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of time for successful venous access [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard
Standard IV Access without device
VeinViewer
IV access with VeinViewer device

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients at a medical facility requiring IV access.

Criteria

Inclusion Criteria:

  • Requires peripheral venous access
  • Intact skin on areas of assessment
  • Patient and/or parent or legal guardian is able to understand consent

Exclusion Criteria:

  • No Intact skin
  • Patient is under anesthesia during peripheral venous access
  • Patient is not a suitable candidate, as determined by the discretion of the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638065

Locations
United States, California
LA County Hospital
Los Angeles, California, United States, 90033
United States, Illinois
Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
Sponsors and Collaborators
Christie Medical Holdings, Inc.
  More Information

No publications provided

Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01638065     History of Changes
Other Study ID Numbers: CP1011
Study First Received: July 9, 2012
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Christie Medical Holdings, Inc.:
vein identification
vascular access

ClinicalTrials.gov processed this record on April 16, 2014