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

NCT ID: NCT02345109

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2014-12-31

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%.

Conditions

Weight; Body Fat Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transtek DUT

Intervention Type: DEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.

Measure each participants by Transtek DUT.

Reference

Intervention Type: DEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

Reference

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

Group Type: EXPERIMENTAL

Transtek DUT

Intervention Type: DEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.

Measure each participants by Transtek DUT.

Reference

Intervention Type: DEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

Interventions

Transtek DUT

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.

Measure each participants by Transtek DUT.

Intervention Type: DEVICE

Reference

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male, female

Exclusion Criteria

• Below 10 years old

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Leo Wang

OTHER

Sponsor Role: lead

Responsible Party

Leo Wang

Team Leader

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guoqing Li, Director

Role: PRINCIPAL_INVESTIGATOR

Wuhou District Hospital

Locations

Wuhou District Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

BTS15001

Identifier Type: OTHER

Identifier Source: secondary_id

15001_Analyzer

Identifier Type: -

Identifier Source: org_study_id