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

This study has been completed.
Sponsor:
Collaborator:
Vue Tek Scientific
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01138228
First received: March 3, 2010
Last updated: June 4, 2010
Last verified: February 2010
  Purpose

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.


Condition
Vision

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Validation of Vue Tek Digital Vein Viewing Device

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    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.


Enrollment: 106
Study Start Date: February 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria
  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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01138228

Locations
United States, New York
St. Luke's Roosevelt Hospitals
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Vue Tek Scientific
Investigators
Principal Investigator: Franco Resta-Flarer, M.D. St. Luke's Roosevelt Hospitals
  More Information

No publications provided

Responsible Party: Franco Resta-Flarer, M.D., St. Luke's Roosevelt Hospitals
ClinicalTrials.gov Identifier: NCT01138228     History of Changes
Other Study ID Numbers: VF Validation
Study First Received: March 3, 2010
Last Updated: June 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
intravenous cannulation
vein identification
vascular identification
vein cannulation

ClinicalTrials.gov processed this record on September 18, 2014