Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models) (15001Analy)

Leo Wang

Status: Completed

Conditions: Body Fat Disorder; Weight

Treatments: Device: Transtek DUT; Device: Reference

Study type: Interventional

Funder types: Other

Identifiers

NCT02345109

15001_Analyzer

BTS15001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 60 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male, female

Exclusion criteria

• Below 10 years old

Trial design

60 participants in 2 patient groups

Transtek DUT

Experimental group

Description:

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.

Treatment:

Device: Reference

Device: Transtek DUT

Reference

Experimental group

Description:

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

Treatment:

Device: Reference

Device: Transtek DUT