Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight? (VFvalidation)

Validation of Vue Tek Digital Vein Viewing Device

VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:

1. Primary Objective:

   To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.

2. Secondary Objective:

To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.

Validation Ancillary Endpoints

1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.

Study Overview

• Status: Completed
• Conditions: Vision

Detailed Description

Validation methodology:

Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.

Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • St. Luke's Roosevelt Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ages 4 weeks and above Light skin Dark skin Normal weight Obese weight

Description

1. Inclusion Criteria: All subjects will be automatically enrolled on a walk-in basis.
2. Exclusion Criteria: No walk-in subjects will be excluded from enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal vision; This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision).
Vein Imaging Device; This within-subjects design is counter balanced for order. Each operator sees the subject's arm either initially with the normal eye or with the device, then repeats with the second condition (i.e., device or normal vision).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.	Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.	Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. Number of veins identified by normal vision is compared to number of veins identified with the device in a counter balanced design.	Immediate

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborators: Vue Tek Scientific
• Investigators: Principal Investigator: Franco Resta-Flarer, M.D., St. Luke's Roosevelt Hospitals

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (ESTIMATE): June 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2010
• Last Update Submitted That Met QC Criteria: June 4, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: intravenous cannulation; vein identification; vascular identification; vein cannulation
• Other Study ID Numbers: VF Validation