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A Comprehensive Look at Vascular Access

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01638065
First Posted: July 11, 2012
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.
  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 ]

Secondary Outcome Measures:
  • Amount of time for successful venous access [ Time Frame: 1 day ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01638065     History of Changes
Other Study ID Numbers: CP1011
First Submitted: July 9, 2012
First Posted: July 11, 2012
Last Update Posted: February 3, 2014
Last Verified: January 2014

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