Text Size

Clinical Trail of Transtek Glass Body Fat Analyzer (GBFA)

This study has been completed.
Sponsor:
Collaborator:
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International
ClinicalTrials.gov Identifier:
NCT01440894
First received: September 25, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  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. 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 Intervention
Weight
Body Fat Disorder
Bone Mass
 Device: Comparison test

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BTS International:

Primary Outcome Measures:
  • Verify the accuracy of measure functions of device [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Verify the functions and efficiency of these devices compare with a specified product.


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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%.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leo Wang, Team leader, BTS International
ClinicalTrials.gov Identifier: NCT01440894     History of Changes
Other Study ID Numbers: TranstekGBFA11003, BTS-TRANS03
Study First Received: September 25, 2011
Last Updated: September 25, 2011
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013