Clinical Trial of Transtek Body Fat Analyzer (GBF-1251-B & Other 3 Models) (BS-BT)

Leo Wang

Status: Completed

Conditions: Bone Mass; Body Fat Disorder; Weight

Treatments: Device: Transtek 950D; Device: Transtek 125X

Study type: Interventional

Funder types: Other

Identifiers

NCT01763775

BTS13001 (Other Identifier)

13001_Body Scale

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-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
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 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:

   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-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B; and reference device: GBF-950-D).
   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: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male,female

Exclusion criteria

• below 18 years old

Trial design

50 participants in 2 patient groups

Transtek 125X

Experimental group

Description:

Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B.

Treatment:

Device: Transtek 950D

Device: Transtek 125X

Transtek 950D

Experimental group

Description:

Measured by Reference (Transtek 950D): GBF-950-D.

Treatment:

Device: Transtek 950D

Device: Transtek 125X