Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009

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

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.

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Detailed Description

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177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject.

Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.

Conditions

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Body Fat

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* All population who meet with the requirements described on the user's manual.

Exclusion Criteria

* Pregnant women.
* Individuals who have a pacemaker or any other internal medical device.
* Population whose weight is under 15 Kg and less than 135 cm tall.

Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes