Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Description:
The objective of this study is to demonstrate the performance of Modulated Imaging Inc.’s
(MI) next generation Spatial Frequency Domain Imaging (SFDI) system, "The Ox-Imager Mini".
Potential circulatory compromise will be imaged in healthy volunteers using both the subject
and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model
is an established paradigm to introduce transient ischemia in skin and the the subjects will
be imaged during this time. The primary endpoint will be to measure significant decrease in
tissue oxygen saturation after occlusion for both predicate and subject devices.
Condition:
Circulatory; Change
Treatment:
The Ox-Imager Mini (Desaturation)
Start Date:
May 30, 2018
Sponsor:
Modulated Imaging Inc.
For More Information:
https://clinicaltrials.gov/show/NCT03563105