Clinical Trial of Transtek Body Fat Analyzer (GBF-1251-B & Other 3 Models)
NCT ID: NCT01763775
Last Updated: 2013-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-10-31
2012-10-31
Brief Summary
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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-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
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Detailed Description
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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.
2. Target Subject:
The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old.
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-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B; and reference device: GBF-950-D).
6. Repeat step 1) to 5) for each subject.
4. Note:
1. No motion and speaking are allowed during the measurement.
2. All DUT use the same algorithms 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\~70%.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
NONE
Study Groups
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Transtek 125X
Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B.
Transtek 125X
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
Transtek 950D
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
Transtek 950D
Measured by Reference (Transtek 950D): GBF-950-D.
Transtek 125X
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
Transtek 950D
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
Interventions
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Transtek 125X
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
Transtek 950D
Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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West China Hospital
OTHER
Leo Wang
OTHER
Responsible Party
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Leo Wang
Team Leader
Principal Investigators
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Guoqing Li, Director
Role: PRINCIPAL_INVESTIGATOR
Wuhou District Hospital
Locations
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Wuhou District Hospital
Chengdu, Sichuan, China
Countries
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Other Identifiers
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BTS13001
Identifier Type: OTHER
Identifier Source: secondary_id
13001_Body Scale
Identifier Type: -
Identifier Source: org_study_id
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