An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.
研究概览
简要总结
A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.
详细描述
The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.
排除标准
- 未提供
研究组 & 干预措施
SVSS and reference devices
Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor.
干预措施: SVSS and reference devices (Device)
结局指标
主要结局
Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.
时间窗: DAY 1
Accuracy of investigational device compared to the reference devices.
次要结局
未报告次要终点