Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Wo-Yun Lee, Masters
- 电话号码：+886975056142
- 邮箱：ginnylee6174@gmail.com
研究联系人备份
- 姓名：Tien-Yun Huang, Masters
- 电话号码：+886975056034
- 邮箱：ivyhuang@cgmh.org.tw
学习地点
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Taoyuan、台湾、333
- 招聘中
- ChangGungMH
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接触：
- Tien-Yun Huang, Masters
- 电话号码：+886975056034
- 邮箱：ivyhuang@cgmh.org.tw
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接触：
- Chin-Jung Chen, MD
- 电话号码：+886975365938
- 邮箱：chinjung@cgmh.org.tw
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首席研究员：
- Chin-Jung Chen, MD
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副研究员：
- Ching-Tai Huang, MD
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副研究员：
- Ming-Chou Chiang, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 1. Male or female aged between 0-100 years.
- 2. Patient agrees to participate in the trial and sign informed consent.
Exclusion Criteria:
- 1. Those who have any broken skin or skin diseases on the part of the body which is the test site of the BLE thermometer, Including the underarms and the back of the body.
- 2. Those whose test site of the BLE thermometer are known to be contaminated by uncle arable body fluids, or lead to the inaccurate of the BLE thermometer.
- 3. Those who have restlessness or other conditions that make them unable to tolerate the temperature measurement procedure.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Single group
This study is specially designed according to its age range and customized/non-customized range, and meets the requirements of ISO 80601-2-56 test population (table). Comply with the age range and population requirements of ISO 80601-2-56, as well as clinical and subject trials, including news to the population over five years old, and hopefuls must account for at least 30% of the total and less than 50% of the total. Each subject uses Q-temp-w1 to measure axillary temperature and obtains 3 temperature values, and at the same time uses a reference body temperature patch (Omron thermometer MC-171W) to measure the other side axillary temperature, and 1 is measured Temperature value data. Perform clinical efficacy analysis based on the measurement results. The main evaluation indicators of the trial include clinical bias, limits of agreement, and clinical repeatability. |
Q-temp-w1 is a contact type body temperature patch developed by Quanta Computer Co., Ltd.
It is mainly used to measure the body temperature of the human body.
It can be used for general body temperature measurement, home temperature measurement records and medical tracking.
Omron thermometer(MC-171W) is mainly used to measure the body temperature of the human body.
The reference temperature patch used in this study is the OMRON thermometer, model: MC-171W.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical bias
大体时间：10 min
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Use the first value of the 3 test patch body temperature data to calculate and analyze the paired data of the test subject with the reference body temperature data.
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10 min
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety /Adverse Event Outcome Measure
大体时间：20 min / 24 hour (until recovered if it's SAE)
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Number of Participants with Serious and Non-Serious Adverse Events
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20 min / 24 hour (until recovered if it's SAE)
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合作者和调查者
调查人员
- 首席研究员：Chin-Jung Chen, MD、Chang Gung Medical fundation
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- QOCA-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Q-temp-w1的临床试验
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Taiwan Sunpan Biotechnology Development Co., Ltd.Virginia Contract Research Organization Co., Ltd.完全的
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Kenneth PalmerUnited States Department of Defense招聘中
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Medical University of Warsaw招聘中
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Children's Hospital Medical Center, Cincinnati完全的