ClearView Predicate Comparison Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Correlation Between ClearView and Predicate
研究概览
简要总结
This study serves as a comparison study between the EPIC ClearView and a predicate device.
详细描述
The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to be used to determine autonomic response as psychological indicators by measuring the electrical resistance of the skin. The EPIC ClearView is a non-invasive digital bioelectrography instrument that is used to assess the electrophysiology of humans. The measurements are digital photographs taken in a brief exposure to an electric field. These measurements are quantified to produce a standardized Response Scale.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: Male or Female.
- •Age range: 18 to
- •The subject is able to understand and provide signed consent for the procedure.
- •Every effort will be given to balance subjects by gender, age, and race.
排除标准
- •Subjects < 18 years in age or > 85 years in age.
- •Inability or unwillingness to provide informed consent.
- •Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.
- •Subjects missing all or part of any of their fingers.
- •Subjects with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.
结局指标
主要结局
Correlation Between ClearView and Predicate
时间窗: At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.)
The primary objective of this study is to perform a point-to-point comparison of the EPIC ClearView™ galvanic skin response hand measurements (on a 0-25 scale) to those of a predicate device (on a 0-100 scale). We hypothesize that there will be a statistically significant correlation between the galvanic skin response measurements made by the two devices.
次要结局
未报告次要终点