Video Documentation of Localized Complications

October 17, 2011 updated by: Christie Medical Holdings, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Key Biologics LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adult volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after flush-Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after attempt-Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edward P Scott, MD, Key Biologics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 17, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • CP1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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