Video Documentation of Localized Complications
1 other identifier
observational
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedOctober 18, 2011
October 1, 2011
Same day
October 12, 2011
October 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Video Documentation of localized vascular access complications
Immediately after attempt-Day 1
Eligibility Criteria
Healthy adult volunteers
You may qualify if:
- Must be 18 years of age or older
- Must be considered in good health by investigator
- Must be able to read and understand English
You may not qualify if:
- Less than 18 years of age
- Known allergy to Heparin
- History of HIT (Heparin-induced thrombocytopenia)
- Unable to read and understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Key Biologics LLC
Memphis, Tennessee, 38104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Edward P Scott, MD
Key Biologics, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 17, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 18, 2011
Record last verified: 2011-10