NCT01360619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
Last Updated

May 25, 2011

Status Verified

October 1, 2007

Enrollment Period

3 months

First QC Date

May 24, 2011

Last Update Submit

May 24, 2011

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.

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All population who meet with the requirements described on the user's manual.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aguiflai Iberica, s.l

Vilassar de Mar, Barcelona, 08340, Spain

Location

Study Officials

  • Angel P Ferre, Telecommunications Engineer

    Aguiflai Iberica, S.L.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 25, 2011

Study Start

June 1, 2007

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

May 25, 2011

Record last verified: 2007-10

Locations

ES(1)