Clinical trial NCT01138228: Does the VTS1000 Infra Red Vein Imager Allow Better Identification of Veins Than Normal Eyesight?
Official title: Validation of Vue Tek Digital Vein Viewing Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision
Keywords: intravenous cannulation
vein identification
vascular identification
vein cannulation
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Vue Tek Scientific
First posted: 2010-06-07
Enrollment: 106
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages 4 weeks and above Light skin Dark skin Normal weight Obese weight

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. 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.

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 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.

Primary outcomes:
measure: To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
timeFrame: Immediate
Secondary outcomes:
measure: To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
timeFrame: Immediate
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hospitals
state: New York
Study officials:
affiliation: St. Luke's Roosevelt Hospitals
name: Franco Resta-Flarer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: