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.

Study Overview

• Status: Completed
• Conditions: 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

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Vilassar de Mar, Barcelona, Spain, 08340
      • Aguiflai Iberica, s.l

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Aguiflai Iberica, S.L.
• Investigators: Principal Investigator: Angel P Ferre, Telecommunications Engineer, Aguiflai Iberica, S.L.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion: October 1, 2007

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 25, 2011
• Last Update Submitted That Met QC Criteria: May 24, 2011
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.
• Other Study ID Numbers: K8-FAT-05062007