Clinical Trial of Transtek Body Fat Analyzer (GBF-1251-B & Other 3 Models)

NCT ID: NCT01763775

Last Updated: 2013-01-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-10-31

Brief Summary

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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-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.

Detailed Description

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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.
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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Weight Body Fat Disorder Bone Mass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

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.

Group Type EXPERIMENTAL

Transtek 125X

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Transtek 125X

Intervention Type DEVICE

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

Intervention Type DEVICE

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).

Intervention Type DEVICE

Transtek 950D

Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* male,female

Exclusion Criteria

* below 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

Leo Wang

OTHER

Sponsor Role lead

Responsible Party

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Leo Wang

Team Leader

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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China

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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