ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trail of Transtek Glass Body Fat Analyzer (GBFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01440894
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : September 27, 2011
Sponsor:
Collaborator:
BTS International
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. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
  4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).
  5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.
  6. Statistical methodology used: Description of statistical methods.
  7. Result: Efficiencies of Transtek devices and predicate device are in the same level.

Condition or disease Intervention/treatment
Weight Body Fat Disorder Bone Mass Device: Comparison test

Detailed Description:

Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.

Investigator: Dr. Stephen Feng, Leader; Fan Futao, Nurse A; Wu Yanting, Nurse B.

Contact Dr. James Zhu Tel: +86 760 88823818 Used Equipments DUT (Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Reference Device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device). Test Protocol

  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.

    Note: GBF-733-W1 and BF-1039 have not bone mass functions. So it just collects weight, body fat, total body water, and muscle mass data.

  2. Target Subject:

    The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. Patient's population analysis is bellow.

  3. Test procedures 1) Record the name, age, and gender values 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-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D; and reference device: GBF-950).

6) Repeat step 1) to 5) for each subject. 5. Note:

  1. No motion and speaking are allowed during the measurement.
  2. All DUT use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency.
  3. Test environment: Temperature: 22±1℃; Relative humidity: 40~50%.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Verify the Functions and Efficiency of Transtek Glass Body Fat Analyzer, GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D.
Study Start Date : February 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Group/Cohort Intervention/treatment
Body Analysis Device: Comparison test

Reference Device: Transtek Glass Body Analyzer, GBF-950, accuracy: ±0.1kg and range: 0-180kg.

DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Other Name: Brand name: Transtek



Primary Outcome Measures :
  1. Verify the accuracy of measure functions of device [ Time Frame: 8 days ]
    Verify the functions and efficiency of these devices compare with a specified product.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The subject population included patients whose age is above 18 years old. Male or Female.
Criteria

Inclusion Criteria:

  • male,female

Exclusion Criteria:

  • below 18 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): NCT01440894


Locations
China, Guangdong
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528403
Sponsors and Collaborators
Leo Wang
BTS International
Investigators
Principal Investigator: Stephen Feng, Director Zhongshan City People's Hospital

Additional Information:
Responsible Party: Leo Wang, Team leader, BTS International
ClinicalTrials.gov Identifier: NCT01440894     History of Changes
Other Study ID Numbers: TranstekGBFA11003
BTS-TRANS03 ( Other Identifier: BTSInternational )
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases