NCT02200458

Brief Summary

This study will look at the performance capabilities of software for VeinViewer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

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

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 9, 2015

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

July 21, 2014

Results QC Date

February 2, 2015

Last Update Submit

March 3, 2015

Conditions

Vascular Access Complication

Outcome Measures

Primary Outcomes (1)

  • Number of Participants for Whom Successful Visualization of Vasculature Was Achieved

    One day

Study Arms (1)

VeinViewer

EXPERIMENTAL

Vascular imaging technology will be used to visualize peripheral vasculature.

Device: VeinViewer

Interventions

VeinViewerDEVICE

Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.

VeinViewer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years of age or older
  • Must be considered to be in overall good health by investigator
  • Must pass all prescreening questions
  • Must be able to read and understand English

You may not qualify if:

  • Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.
  • IV cannulation in the arms or hands in the previous 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christie Medical Holdings, Inc.

Memphis, Tennessee, 38104, United States

Location

Results Point of Contact

Title
Clinical Affairs Manager
Organization
Christie Medical Holdings, Inc.
christiemedinfo@christiedigital.com
901-721-0330

Study Officials

  • Gregory Schears, MD

    Christie Medical Holdings, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 25, 2014

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

March 9, 2015

Results First Posted

March 9, 2015

Record last verified: 2015-03

Locations

US(1)