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

Body Fat Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360619
• Other study ID #: K8-FAT-05062007
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: May 24, 2011
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Aguiflai Iberica, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Body Fat

Locations

Country	Name	City	State
Spain	Aguiflai Iberica, s.l	Vilassar de Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Aguiflai Iberica, S.L.

Country where clinical trial is conducted

Spain,