NCT04876664Unknown不适用
Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 主要终点
- Data collection of NIBP measurement
研究概览
简要总结
A study to collect data recorded by devices for cNIBP evaluation purposes.
详细描述
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.
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
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 male or female, aged 18 years or older (≥18 years);
- •Willing and able to give informed consent for participation in the study;
- •Able and willing to comply with all the study requirements.
排除标准
- •Who is pregnant or lactating;
- •Who is a smoker;
- •Who has consumed alcohol in the last 24 hours;
- •Who has been previously diagnosed with Ataxia or balance disorder;
- •Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
- •Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
- •Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;
研究组 & 干预措施
Ambulatory monitoring solution
Experimental
this study has only one arm
干预措施: measuring blood pressure with noninvasive blood pressure device (Device)
结局指标
主要结局
Data collection of NIBP measurement
时间窗: through study completion, average of one day
To collect data recorded by devices for cNIBP evaluation purposes.
次要结局
- Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues(through study completion, an average of one day)
研究者
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