An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 95
- 主要终点
- Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61
研究概览
简要总结
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
详细描述
The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.
- Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.
- Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.
- Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.
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
盲法说明
Vital sign results obtained by the device under study are not displayed on phone screen.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent
- •18 and 80 years old
- •no history or risk for developing lymphedema
- •no arteriovenous fistula in the right arm
- •no right limb amputation up to and including the right index finger
- •ability to obtain 3 readings from the device during the screening/training session.
排除标准
- •history of arrhythmia
- •arteriovenous fistula in the right arm
- •lymphedema or high risk for developing lymphedema in the right arm
- •inability to follow the procedures of the study
- •inability to hold the study device as instructed
- •inability to obtain 3 readings from the study device during the screening session
- •previous enrolment into the current study
- •enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.
研究组 & 干预措施
V-Sensor Device User
This diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider.
干预措施: V-sensor device user (Device)
结局指标
主要结局
Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61
时间窗: 4 months
Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device.
Respiration rate accuracy
时间窗: 4 months
Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate
Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.
时间窗: 4 months
Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias \<= 3.0°C and a clinical repeatability \<= 3.0°C.
Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2
时间窗: 4 months
For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg.
Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.
时间窗: 4 months
The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2
次要结局
- No serious adverse device effects are reported.(4 months)