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NCT02200458 Clinical Trial

Near-infrared Software Performance Study

Vascular Access Complication Clinical Trial

Official title:
Near-Infrared Software Performance Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02200458
Other study ID # CP1019
Secondary ID
Status Completed
Phase N/A
First received July 21, 2014
Last updated March 3, 2015
Start date November 2012
Est. completion date December 2014

Study information
Verified date March 2015
Source Christie Medical Holdings, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will look at the performance capabilities of software for VeinViewer.

Description:

This study will look at the performance capabilities of future software for VeinViewer.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Must be 18 years of age or older

2. Must be considered to be in overall good health by investigator

3. Must pass all prescreening questions

4. Must be able to read and understand English

Exclusion Criteria:

1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.

2. IV cannulation in the arms or hands in the previous 4 weeks.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• VeinViewer
Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.

Locations
Country Name City State
United States Christie Medical Holdings, Inc. Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Christie Medical Holdings, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants for Whom Successful Visualization of Vasculature Was Achieved One day No
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