Near-infrared Software Performance Study

Near-Infrared Software Performance Study

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

Study Overview

• Status: Completed
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: VeinViewer

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Christie Medical Holdings, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VeinViewer; Vascular imaging technology will be used to visualize peripheral vasculature.	Device: VeinViewer; Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants for Whom Successful Visualization of Vasculature Was Achieved	One day

Collaborators and Investigators

• Sponsor: Christie Medical Holdings, Inc.
• Investigators: Principal Investigator: Gregory Schears, MD, Christie Medical Holdings, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CP1019