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

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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Key information

Conditions

Body Fat

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aguiflai Iberica, s.l

Vilassar de Mar, Barcelona, 08340, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Sponsors and collaborators

Lead sponsor

Aguiflai Iberica, S.L.

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: May 25, 2011
Registry last updated: May 25, 2011

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.

Published trials that share one or more normalized conditions with this study.

Completed