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

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ClinicalTrials.gov Identifier: NCT02345109
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Leo Wang, BTS International

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.

Condition or disease Intervention/treatment Phase
Weight Body Fat Disorder Device: Transtek DUT Device: Reference Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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.




Primary Outcome Measures :
  1. BMI (Body Mass Index) [ Time Frame: 5 Days ]
    Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 1 Day ]
    Body Weight



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, female

Exclusion Criteria:

  • Below 10 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345109


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

Responsible Party: Leo Wang, Team Leader, BTS International
ClinicalTrials.gov Identifier: NCT02345109     History of Changes
Other Study ID Numbers: 15001_Analyzer
BTS15001 ( Other Identifier: BTSInternational )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Leo Wang, BTS International:
weight
total body water
body fat
muscle mass
bone mass
BMI
visceral fat
calories

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases