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

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

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.

Study Overview

• Status: Completed
• Conditions: Weight; Body Fat Disorder
• Intervention / Treatment: Device: Transtek DUT; Device: Reference

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Wuhou District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male, female

Exclusion Criteria:

• Below 10 years old

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Device: Reference; Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.
Experimental: Reference; Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533.	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.; Device: Reference; Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (Body Mass Index)	Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.	5 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body Weight	1 Day

Collaborators and Investigators

• Sponsor: Leo Wang
• Collaborators: West China Hospital
• Investigators: Principal Investigator: Guoqing Li, Director, Wuhou District Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 22, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: muscle mass; visceral fat; BMI; bone mass; weight; total body water; body fat; calories
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: 15001_Analyzer; BTS15001 (Other Identifier: BTSInternational)