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Clinical Test for Transtek Glass Body Analyzer (GBA)

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: NCT01296048
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : December 23, 2011
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. DUT: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
  4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (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 West China Medical College Clinical Investigator Team at Wuhou District Hospital, No. 9 Tongzilin Road, Wuhou District, Chengdu 610041, P. R. China.

Investigator: Catharine Zhang, Nurse A; Vivian Luo, Nurse B; Dr. James Zhu, Sponsor.

Contact Dr. James Zhu Tel: +86 1330 8036568 Used Equipments DUT (Device Under Test): Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, and SA-15.

Reference Device: Scaleman Body Fat Scales, FS-148BW1 (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-835 has not total body water, bone mass, and muscle mass functions. So it just collects weight and body fat 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, 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-830, GBF-835, GBF-950, and SA-15; and reference device: FS-148BW1).

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: 20±1℃; Relative humidity: 40~50%.

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15
Study Start Date : November 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

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
Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.
Other Names:
  • Brand names: Scaleman
  • Serial numbers: SBFS1002-351
  • Code name: FS-148BW1



Primary Outcome Measures :
  1. Verify the accuracy of measure functions of device [ Time Frame: 10 days ]
    Verify the functions and efficiency of these devices compare with a specified product.



Information from the National Library of Medicine

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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): NCT01296048


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: NCT01296048     History of Changes
Other Study ID Numbers: Transtek GBA
BTS-TRANS02 ( Other Identifier: BTSInternational )
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 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