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Clinical Test for Transtek Glass Body Analyzer (GBA)

This study has been completed.
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Leo Wang, BTS International
ClinicalTrials.gov Identifier:
NCT01296048
First received: February 12, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  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: 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 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 Analyzer, GBF-830, GBF-835, GBF-950, SA-15

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: 10 days ] [ Designated as safety issue: Yes ]
    Verify the functions and efficiency of these devices compare with a specified product.


Enrollment: 74
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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%.
  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: 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
  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: NCT01296048     History of Changes
Other Study ID Numbers: Transtek GBA, BTS-TRANS02
Study First Received: February 12, 2011
Last Updated: December 22, 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 23, 2013