Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Significant decrease in StO2 during occlusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
排除标准
- •History of congestive heart failure
- •Patients with existing wound or ulcer.
- •Rheumatoid arthritis
- •Pregnant or lactating women
研究组 & 干预措施
Desaturation
Vascular Occlusion Test
干预措施: The Ox-Imager Mini (Desaturation) (Device)
结局指标
主要结局
Significant decrease in StO2 during occlusion
时间窗: immediate
significant decrease in StO2 during occlusion
次要结局
未报告次要终点