Video Documentation of Localized Complications

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. Identifier: NCT01453322
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.

Brief Summary:
The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.

Condition or disease
Vascular Access

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology
Study Start Date : September 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Primary Outcome Measures :
  1. Valve and Refill Confirmation [ Time Frame: Immediately after flush-Day 1 ]
    Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.

Secondary Outcome Measures :
  1. Video Documentation of localized vascular access complications [ Time Frame: Immediately after attempt-Day 1 ]
    Using VeinViewer, the user will be able to detect hematomas and infiltrations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers

Inclusion Criteria:

  • Must be 18 years of age or older
  • Must be considered in good health by investigator
  • Must be able to read and understand English

Exclusion Criteria

  • Less than 18 years of age
  • Known allergy to Heparin
  • History of HIT (Heparin-induced thrombocytopenia)
  • Unable to read and understand English

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 identifier (NCT number): NCT01453322

United States, Tennessee
Key Biologics LLC
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Christie Medical Holdings, Inc.
Principal Investigator: Edward P Scott, MD Key Biologics, LLC

Responsible Party: Christie Medical Holdings, Inc. Identifier: NCT01453322     History of Changes
Other Study ID Numbers: CP1009
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Christie Medical Holdings, Inc.:
Vascular Access
IV complications
VeinViewer Vision