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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360619
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Information provided by:
Aguiflai Iberica, S.L.

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.

Condition or disease
Body Fat

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.

Study Type : Observational
Enrollment : 177 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Study Start Date : June 2007
Actual Primary Completion Date : September 2007
Study Completion Date : October 2007

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
To include the maximum types of patients, the selection was opened to all the general public who could use the multifunction Keito in a public site, where is is intended to be placed. The test was carried out following the user's manual rules about who can use the device.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360619

Aguiflai Iberica, s.l
Vilassar de Mar, Barcelona, Spain, 08340
Sponsors and Collaborators
Aguiflai Iberica, S.L.
Principal Investigator: Angel P Ferre, Telecommunications Engineer Aguiflai Iberica, S.L.

Responsible Party: Angel Pons ferre, Aguiflai Iberica, S.L. Identifier: NCT01360619     History of Changes
Other Study ID Numbers: K8-FAT-05062007
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: October 2007

Keywords provided by Aguiflai Iberica, S.L.:
To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.