Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models)

Study Overview
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Brief Summary
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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-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533. Study endpoints: DUT and the comparison device are substantial equivalence. Statistical methodology used: Description of statistical methods.

Detailed Description
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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. Target Subject: The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old. Test procedures: Record the name, age, gender, and height of each subject. Let subject seated calmly for two minutes before test, dry the feet. Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value. For each subject, repeat 3) to get 3 pairs measurements. 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). Repeat step 1) to 5) for each subject. Note: No motion and speaking are allowed during the measurement. All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency. Test environment: Temperature: 22±1℃; Relative humidity: 40 70%.

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

Conditions
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Weight, Body Fat Disorder

Intervention / Treatment
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* Device: Transtek DUT
* Device: Reference


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, female Exclusion Criteria: Below 10 years old

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transtek DUT<br>Which measured by 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. | Device: Transtek DUT<br>* Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT.<br>Device: Reference<br>* Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.<br>|
| Experimental: Reference<br>Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533. | Device: Transtek DUT<br>* Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT.<br>Device: Reference<br>* Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (Body Mass Index) | Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat. | 5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Body Weight | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight, BMI, total body water, body fat, muscle mass, bone mass, visceral fat, calories