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

NCT01138228 | Completed

• 1 other identifier: VF Validation
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Primary Objective:
2. 2.Secondary Objective:

Conditions

Vision

Keywords

intravenous cannulation; vein identification; vascular identification; vein cannulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Immediate

Study Arms (2)

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).

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Vue Tek Scientific: collaborator

Study Sites (1)

St. Luke's Roosevelt Hospitals

New York, New York, 10019, United States

Location

Study Officials

• Franco Resta-Flarer, M.D.

  St. Luke's Roosevelt Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: June 7, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 7, 2010

Record last verified: 2010-02

Locations

US (1)