NCT04472208已完成不适用
Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- User feedback survey about the use of the Ambulatory Monitoring Solution
研究概览
简要总结
A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.
详细描述
The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory 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
- Other
- 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
- 否
入选标准
- •Male or female aged 18 years or older (≥18 years);
- •Able and willing to provide written informed consent independently.
排除标准
- •Have previously participated in this study (no subject may participate more than once);
- •Have an implantable pacemaker;
- •Diagnosed with infection requiring isolation; OR
- •Known to be pregnant and/or breast feeding;
结局指标
主要结局
User feedback survey about the use of the Ambulatory Monitoring Solution
时间窗: 5 days
The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected.
次要结局
未报告次要终点
研究者
研究点 (2)
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