Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
- Conditions
- Circulatory; Change
- Interventions
- Device: The Ox-Imager Mini (Desaturation)
- Registration Number
- NCT03563105
- Lead Sponsor
- Modulated Imaging Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Over 18 years of age
- History of congestive heart failure
- Patients with existing wound or ulcer.
- Rheumatoid arthritis
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Desaturation The Ox-Imager Mini (Desaturation) Vascular Occlusion Test
- Primary Outcome Measures
Name Time Method Significant decrease in StO2 during occlusion immediate significant decrease in StO2 during occlusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Orange County Wound and Hyperbaric
🇺🇸Santa Ana, California, United States