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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
  Purpose

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
Vascular Access

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adult volunteers

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453322

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

No publications provided

Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01453322     History of Changes
Other Study ID Numbers: CP1009
Study First Received: October 12, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014