NCT01807507

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

March 6, 2013

Last Update Submit

January 30, 2014

Conditions

Vein Width

Keywords

VeinsVascular Access

Outcome Measures

Primary Outcomes (1)

  • Device validation versus ultrasound

    The focus of this study is to understand the clinical effectiveness of the device.

    Immediately after assessment-Day 1

Study Arms (1)

Healthy Volunteers

Device: VeinViewer

Interventions

VeinViewerDEVICE

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.

Healthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • Must be 18 years of age or older
  • Must be able to read and understand English to understand the consent letter

You may not qualify if:

  • Less than 18 years of age
  • Unable to read and understand English to understand the consent letter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christie Medical Holdings, Inc.

Kitchener, Ontario, N2G 4Y7, Canada

Location

Study Officials

  • Ben Wagner, MS

    Christie Medical Holdings, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

July 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

CA(1)