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NCT01453322 Clinical Trial

Video Documentation of Localized Complications

Vascular Access Clinical Trial

Official title:
Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01453322
Other study ID # CP1009
Secondary ID
Status Completed
Phase N/A
First received October 12, 2011
Last updated October 17, 2011
Start date September 2011
Est. completion date September 2011

Study information
Verified date October 2011
Source Christie Medical Holdings, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2011
Est. primary completion date September 2011
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 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Key Biologics LLC 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 Valve and Refill Confirmation Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound. Immediately after flush-Day 1 No
Secondary Video Documentation of localized vascular access complications Using VeinViewer, the user will be able to detect hematomas and infiltrations. Immediately after attempt-Day 1 No
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