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OpenTrials
Completed

NCT Number: NCT01453322

Video Documentation of Localized Complications

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.

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Key information

Conditions

Vascular Access

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Key Biologics LLC

Memphis, Tennessee, 38104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Christie Medical Holdings, Inc.

Industry

Registry information

Official study title

Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2011
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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