Circulatory; Change
Conditions
Keywords
tissue oxygen saturation
Brief summary
The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.
Detailed 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.
Interventions
DEVICEThe Ox-Imager Mini (Desaturation)
Vascular Occlusion Test
Sponsors
Modulated Imaging Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Vascular Occlusion Test
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years of age
Exclusion criteria
* History of congestive heart failure * Patients with existing wound or ulcer. * Rheumatoid arthritis * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant decrease in StO2 during occlusion | immediate | significant decrease in StO2 during occlusion |
Countries
United States
Outcome results
None listed