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临床试验/NCT05182684
NCT05182684Unknown不适用

A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device

Seoul National University Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
4
主要终点
The proportion of data collected

研究概览

简要总结

A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

详细描述

The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

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

性别
Male
接受健康志愿者

入选标准

  • Healthy adult male volunteers who can use an Android smartphone.
  • The subjects who voluntarily agree to participate and give written informed consent.

排除标准

  • The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions.
  • The subjects who are judged to be inappropriate for the clinical trials to participate.

结局指标

主要结局

The proportion of data collected

时间窗: 6 hours

Compare actual monitored and server collected times

次要结局

  • The comparison of ventricular rate(6 hours)
  • The comparison of abnormal events(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SeungHwan Lee

Professor

Seoul National University Hospital

研究点 (4)

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