NCT07507903招募中不适用
OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aktiia SA
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blood pressure mean value of differences
研究概览
简要总结
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.
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 informed consent to participate.
- •Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
- •Participants must be 22 to 59 years of age.
- •Participants or witnesses 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 visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential .
- •Participants with known history of clotting disorders or blood clots, 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 sporadic or sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including but not limited to tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
- •Participants suffering from sporadic or sustained reduction of peripheral perfusion that can lead to weak or unstable pressure pulses including but not limited to: Raynaud's disease, diabetes (Type I and Type II), renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma, arteriovenous fistula, and valvular heart diseases.
- •A wrist circumference below 14 cm or above 23 cm.
- •An upper-arm circumference <22 cm 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, or 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.
研究组 & 干预措施
Aktiia.product-G1-US device under test
Other
Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references.
干预措施: Device under test evaluation against references (Device)
结局指标
主要结局
Blood pressure mean value of differences
时间窗: 7 days
The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences
时间窗: 7 days
The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
次要结局
- Heart rate root-mean-square error(7 days)
研究者
研究点 (2)
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