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NCT01807507 Clinical Trial

Clinical Verification Evaluation of VeinViewer® Device

Vein Width Clinical Trial

Official title:
Clinical Verification Evaluation of VeinViewer® Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01807507
Other study ID # CP1016
Secondary ID
Status Completed
Phase N/A
First received March 6, 2013
Last updated January 30, 2014
Start date October 2011
Est. completion date July 2013

Study information
Verified date January 2014
Source Christie Medical Holdings, Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date July 2013
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be 18 years of age or older

- Must be able to read and understand English to understand the consent letter

Exclusion Criteria:

- Less than 18 years of age

- Unable to read and understand English to understand the consent letter

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• VeinViewer
VeinViewer® is designed to improve vascular access treatment standards and provide the highest possible quality in volunteer care. The device is a non-invasive handheld electronic visual aid device designed to project an image of superficial, subcutaneous vascular structures on the surface of the skin. VeinViewer's primary purpose is to assist in vascular visualization for IV starts and blood draws.

Locations
Country Name City State
Canada Christie Medical Holdings, Inc. Kitchener Ontario

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

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Device validation versus ultrasound The focus of this study is to understand the clinical effectiveness of the device. Immediately after assessment-Day 1 No