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

This study has been completed.
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Leo Wang, BTS International
ClinicalTrials.gov Identifier:
NCT01763775
First received: January 5, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention
Weight
Body Fat Disorder
Bone Mass
Device: Transtek 125X
Device: Transtek 950D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B

Resource links provided by NLM:


Further study details as provided by BTS International:

Primary Outcome Measures:
  • BMI (Body Mass Index) [ Time Frame: 5 Day ] [ Designated as safety issue: No ]
    Body Fat, Total Body Water, Muscle Mass, Bone Mass


Secondary Outcome Measures:
  • Weight [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
    Body Weight


Enrollment: 50
Study Start Date: October 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transtek 125X
Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B.
Device: Transtek 125X
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
Device: Transtek 950D
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
Experimental: Transtek 950D
Measured by Reference (Transtek 950D): GBF-950-D.
Device: Transtek 125X
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
Device: Transtek 950D
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).

Detailed 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%.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male,female

Exclusion Criteria:

  • below 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763775

Locations
China, Sichuan
Wuhou District Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Leo Wang
West China Hospital
Investigators
Principal Investigator: Guoqing Li, Director Wuhou District Hospital
  More Information

No publications provided

Responsible Party: Leo Wang, Team Leader, BTS International
ClinicalTrials.gov Identifier: NCT01763775     History of Changes
Other Study ID Numbers: 13001_Body Scale, BTS13001
Study First Received: January 5, 2013
Last Updated: January 7, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by BTS International:
weight
total body water
body fat
muscle mass
bone mass

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 16, 2014