Vision Clinical Trial
Official title:
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.
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.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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