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CompletedNCT01453322Updated Oct 18, 2011

Video Documentation of Localized Complications

An observational study in Vascular Access, sponsored by Christie Medical Holdings, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-18.

Sponsored by Christie Medical Holdings, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Access

Keywords

  • Veins
  • Vascular Access
  • IV complications
  • VeinViewer Vision
03

In context

Lead sponsor

Christie Medical Holdings, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adult volunteers

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

Exclusion Criteria

  • Less than 18 years of age
  • Known allergy to Heparin
  • History of HIT (Heparin-induced thrombocytopenia)
  • Unable to read and understand English
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
06

What researchers measure

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.

    Time frame: Immediately after flush-Day 1

Secondary outcomes

  1. Video Documentation of localized vascular access complications

    Using VeinViewer, the user will be able to detect hematomas and infiltrations.

    Time frame: Immediately after attempt-Day 1

07

Study locations

1 site
  • Key Biologics LLC
    Memphis, Tennessee 38104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01453322
Lead sponsor
Christie Medical Holdings, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2011
Start date
Sep 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Oct 18, 2011

Study contacts

Edward P Scott, MD
principal investigator · Key Biologics, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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