Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- BMI (Body Mass Index)
研究概览
简要总结
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the functions and efficiency of devices.
- Test methods and procedures: Comparison Test.
- Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
- Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
- Study endpoints: DUT and the comparison device are substantial equivalence.
- Statistical methodology used: Description of statistical methods.
详细描述
- Test Purpose:
The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device. 2. Target Subject:
The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. 3. Test procedures:
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Record the name, age, gender, and height of each subject.
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Let subject seated calmly for two minutes before test, dry the feet.
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Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
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For each subject, repeat 3) to get 3 pairs measurements.
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Repeat step 1) to 4) for every device (DUT: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B; and reference device: GBF-950-D).
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Repeat step 1) to 5) for each subject.
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Note:
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No motion and speaking are allowed during the measurement.
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All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
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Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •male,female
排除标准
- •below 18 years old
结局指标
主要结局
BMI (Body Mass Index)
时间窗: 5 Day
Body Fat, Total Body Water, Muscle Mass, Bone Mass
次要结局
- Weight(5 Days)
研究者
Leo Wang
Team Leader
BTS International
