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Completed

NCT Number: NCT02345109

Clinical Trial of Transtek Body Fat Analyzer (GBF-835-N2 & Other 7 Models)

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. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus. 4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533. 5. Study endpoints: DUT and the comparison device are substantial equivalence. 6. Statistical methodology used: Description of statistical methods.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhou District Hospital

Chengdu, Sichuan, 610041, China

About this study

  • Test Purpose:

The aim of clinical test is to collect BMI, body fat, total body water, muscle mass, bone mass, calorie, and visceral fat reading value which measured by DUT and reference device.

  • Target Subject:

The subject database shall contain at least 30 male and 30 female subjects and all above 10 years old.

  • Test procedures:
  • Record the name, age, gender, and height of each subject.
  • Let subject seated calmly for two minutes before test, dry the feet.
  • Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
  • For each subject, repeat 3) to get 3 pairs measurements.
  • Repeat step 1) to 4) for every device (DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus; and reference device: GBF-1251-B and BC-533).
  • Repeat step 1) to 5) for each subject.
  • Note:
  • No motion and speaking are allowed during the measurement.
  • All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
  • Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, female

Exclusion criteria

  • Below 10 years old

Treatment and study plan

Transtek DUT

Device

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.

Measure each participants by Transtek DUT.

Reference

Device

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

Primary outcomes

  1. BMI (Body Mass Index)

    Time frame: 5 Days

    Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.

Secondary outcomes

  1. Weight

    Time frame: 1 Day

    Body Weight

Sponsors and collaborators

Lead sponsor

Leo Wang

Other

Collaborators

  • West China Hospital

Registry information

Official study title

Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, 8 Models

Acronym: 15001Analy

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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