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

February 12, 2011
December 22, 2011
November 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01296048 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Test for Transtek Glass Body Analyzer
Verify the Functions and Efficiency of Transtek Glass Body Analyzer, GBF-830, GBF-835, GBF-950, SA-15

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.

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%.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

The subject population included patients whose age is above 18 years old. Male or Female.

  • Weight
  • Body Fat Disorder
  • Bone Mass
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
Body Analysis
Intervention: Device: Comparison test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male,female

Exclusion Criteria:

  • below 18 years old
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01296048
Transtek GBA, BTS-TRANS02
No
Leo Wang, BTS International
Leo Wang
West China Hospital
Principal Investigator: Guoqing Li, Director Wuhou District Hospital
BTS International
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP