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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360619

Enrollment

177

Registered

2011-05-25

Start date

2007-06-30

Completion date

2007-10-31

Last updated

2011-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Fat

Keywords

To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 82 Years

Healthy volunteers

Yes

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.

Countries

Spain

Outcome results