Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.
详细描述
This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements.
The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG).
The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is greater than 12 years of age at the time of screening.
- •Subject's upper arm circumference is between 20cm and 55cm.
- •Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
- •Subject is willing and able to participate for up to 60 minutes.
排除标准
- •Subject is participating in another clinical study that may interfere with the results of this study.
- •Subject is unable to have a blood pressure measurement taken from either arm for any reason.
- •Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.