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临床试验/NCT02345109
NCT02345109已完成不适用

Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models

Leo Wang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
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:

  1. Objective of the test: To verify the functions and efficiency of devices.
  2. Test methods and procedures: Comparison Test.
  3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.
  4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
  5. Study endpoints: DUT and the comparison device are substantial equivalence.
  6. Statistical methodology used: Description of statistical methods.

详细描述

  1. Test Purpose:

The aim of clinical test is to collect BMI, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by DUT and reference device. 2. Target Subject:

The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old. 3. Test procedures:

  1. Record the name, age, gender, and height of each subject.

  2. Let subject seated calmly for two minutes before test, dry the feet.

  3. Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.

  4. For each subject, repeat 3) to get 3 pairs measurements.

  5. Repeat step 1) to 4) for every device (DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and reference device: GBF-1251-B and BC-533).

  6. Repeat step 1) to 5) for each subject.

  7. Note:

  8. No motion and speaking are allowed during the measurement.

  9. All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.

  10. 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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male, female

排除标准

  • Below 10 years old

结局指标

主要结局

BMI (Body Mass Index)

时间窗: 5 Days

Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.

次要结局

  • Weight(1 Day)

研究者

发起方
Leo Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leo Wang

Team Leader

BTS International

研究点 (1)

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