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Video Documentation of Localized Complications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01453322
First received: October 12, 2011
Last updated: October 17, 2011
Last verified: October 2011
History of Changes

October 12, 2011
October 17, 2011
September 2011
September 2011   (final data collection date for primary outcome measure)
Valve and Refill Confirmation [ Time Frame: Immediately after flush-Day 1 ] [ Designated as safety issue: No ]
Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.
Valve and Refill Confirmation [ Time Frame: Immediately after flush ] [ Designated as safety issue: No ]
Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound.
Complete list of historical versions of study NCT01453322 on ClinicalTrials.gov Archive Site
Video Documentation of localized vascular access complications [ Time Frame: Immediately after attempt-Day 1 ] [ Designated as safety issue: No ]
Using VeinViewer, the user will be able to detect hematomas and infiltrations.
Video Documentation of localized vascular access complications [ Time Frame: Immediately after attempt ] [ Designated as safety issue: No ]
Using VeinViewer, the user will be able to detect hematomas and infiltrations.
Not Provided
Not Provided
 
Video Documentation of Localized Complications
Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy adult volunteers
Vascular Access
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01453322
CP1009
No
Christie Medical Holdings, Inc.
Christie Medical Holdings, Inc.
Not Provided
Principal Investigator: Edward P Scott, MD Key Biologics, LLC
Christie Medical Holdings, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP