NCT01638065

Brief Summary

The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 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

10 months

First QC Date

July 9, 2012

Last Update Submit

January 30, 2014

Conditions

Vascular Access

Keywords

vein identificationvascular access

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be total number of attempts for successful cannulation.

    1 day

Secondary Outcomes (1)

  • Amount of time for successful venous access

    1 day

Study Arms (2)

Standard

Standard IV Access without device

VeinViewer

IV access with VeinViewer device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at a medical facility requiring IV access.

You may qualify if:

  • Requires peripheral venous access
  • Intact skin on areas of assessment
  • Patient and/or parent or legal guardian is able to understand consent

You may not qualify if:

  • No Intact skin
  • Patient is under anesthesia during peripheral venous access
  • Patient is not a suitable candidate, as determined by the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LA County Hospital

Los Angeles, California, 90033, United States

Location

Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

US(2)