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

Body Fat Disorder Clinical Trial

— 15001Analy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345109
• Other study ID #: 15001_Analyzer
• Secondary ID: BTS15001
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 22, 2015
• Start date: December 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: BTS International
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Male, female

Exclusion Criteria:

• Below 10 years old

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders
• Weight

Intervention

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

Locations

Country	Name	City	State
China	Wuhou District Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Leo Wang	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (Body Mass Index)	Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.	5 Days	No
Secondary	Weight	Body Weight	1 Day	No