Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Modulated Imaging Inc.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Significant decrease in StO2 during occlusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Desaturation
Vascular Occlusion Test
Intervention: The Ox-Imager Mini (Desaturation) (Device)
Outcomes
Primary Outcomes
Significant decrease in StO2 during occlusion
Time Frame: immediate
significant decrease in StO2 during occlusion
Secondary Outcomes
No secondary outcomes reported