Near-infrared Software Performance Study

• Sponsor: Christie Medical Holdings, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02200458
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Device: VeinViewer	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Near-Infrared Software Performance Study
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants for Whom Successful Visualization of Vasculature Was Achieved [One day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christie Medical Holdings, Inc.	Memphis	Tennessee	United States	38104

Sponsors and Collaborators

• Christie Medical Holdings, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christie Medical Holdings, Inc.
• ClinicalTrials.gov Identifier: NCT02200458
• Other Study ID Numbers: CP1019
• First Posted: Jul 25, 2014
• Last Update Posted: Mar 9, 2015
• Last Verified: Mar 1, 2015

Study Results

Participant Flow

Arm/Group Title	VeinViewer
Arm/Group Description	Vascular imaging technology will be used to visualize peripheral vasculature. VeinViewer
Period Title: Overall Study
STARTED	62
COMPLETED	62
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	VeinViewer
Arm/Group Description	Vascular imaging technology will be used to visualize peripheral vasculature. VeinViewer
Overall Participants	62
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	21 33.9%
Male	41 66.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	62 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 3.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 11.3%
White	53 85.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Height (CM) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [CM]	168.7 (10.5)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	83.2 (17.6)
Fitzpatrick (Points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Points]	20.2 (7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VeinViewer
Arm/Group Description	Vascular imaging technology will be used to visualize peripheral vasculature. VeinViewer
Measure Participants	62
Number [participants]	62 100%

Adverse Events

Arm/Group Title	VeinViewer
Arm/Group Description	Vascular imaging technology will be used to visualize peripheral vasculature. VeinViewer
All Cause Mortality
	VeinViewer
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	VeinViewer
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Other (Not Including Serious) Adverse Events
	VeinViewer
	Affected / at Risk (%)	# Events
Total	0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.