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

Not Applicable

Completed

• Conditions: Body Fat Disorder; Weight
• Interventions: Device: Transtek DUT; Device: Reference

• Registration Number: NCT02345109
• Lead Sponsor: Leo Wang

Brief Summary

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.

Detailed Description

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.

4. Note:

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

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

3. Test environment: Temperature: 22±1℃; Relative humidity: 40\~70%.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-22
• Last Update Submitted: 2015-01-22
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male, female

Exclusion Criteria

• Below 10 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Transtek DUT	Transtek DUT	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.
Transtek DUT	Reference	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.
Reference	Transtek DUT	Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533.
Reference	Reference	Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533.

Primary Outcome Measures

Name	Time	Method
BMI (Body Mass Index)	5 Days	Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.

Secondary Outcome Measures

Name	Time	Method
Weight	1 Day	Body Weight

Trial Locations

Locations (1)

Wuhou District Hospital; 🇨🇳 Chengdu, Sichuan, China