- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453322
Video Documentation of Localized Complications
October 17, 2011 updated by: Christie Medical Holdings, Inc.
Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- Key Biologics LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adult volunteers
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Valve and Refill Confirmation
Time Frame: Immediately after flush-Day 1
|
Using VeinViewer, the clinician will be able to view valves and refill.
It will be confirmed using Ultrasound.
|
Immediately after flush-Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video Documentation of localized vascular access complications
Time Frame: Immediately after attempt-Day 1
|
Using VeinViewer, the user will be able to detect hematomas and infiltrations.
|
Immediately after attempt-Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward P Scott, MD, Key Biologics, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
October 12, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (Estimate)
October 17, 2011
Study Record Updates
Last Update Posted (Estimate)
October 18, 2011
Last Update Submitted That Met QC Criteria
October 17, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CP1009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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