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OpenTrials
Completed

NCT Number: NCT01138228

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

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.

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Key information

Conditions

Vision

Age range

4 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's Roosevelt Hospitals

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Immediate

    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.

Secondary outcomes

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

    Time frame: Immediate

    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.

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Vue Tek Scientific

Registry information

Official study title

Validation of Vue Tek Digital Vein Viewing Device

Acronym: VFvalidation

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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