NCT06565780已完成不适用
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aktiia SA
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Blood pressure standard deviation of differences
研究概览
简要总结
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
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
- 22 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to provide an informed consent to participate.
- •Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
- •Participants must be 22 to 59 years of age.
- •Participant or witness must be able to read or write in English.
排除标准
- •Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- •Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
- •Participants with known clotting disorders or currently taking a prescription blood thinner.
- •Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
- •Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
- •Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
- •A wrist circumference below 14 cm or above 23 cm.
- •An upper arm circumference < 22cm or > 42cm.
- •Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
- •Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
结局指标
主要结局
Blood pressure standard deviation of differences
时间窗: 23 hours
The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
Blood pressure mean value of differences
时间窗: 23 hours
The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
次要结局
- Heart rate root-mean-square error(23 hours)
研究者
研究点 (2)
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