Body FatNCT01360619
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
An observational study of Body Fat, run by Aguiflai Iberica, S.L. at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat
- How many people
- 177 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2007to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All population who meet with the requirements described on the user's manual.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 177 participants
Sponsor and investigators
- Lead sponsor
- Aguiflai Iberica, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Angel P Ferre, Telecommunications Engineer, Principal investigator, Aguiflai Iberica, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360619
- Sponsor's protocol ID
- K8-FAT-05062007
- Status last verified
- Oct 2007
- First submitted
- 24 May 2011
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
- ClinicalTrials.gov ID
- NCT01360619
- Acronym / sponsor ID
- K8-FAT-05062007
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants
- Lead sponsor
- Aguiflai Iberica, S.L.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All population who meet with the requirements described on the user's manual.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel P Ferre, Telecommunications Engineer principal investigator
Aguiflai Iberica, S.L.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Fat, run by Aguiflai Iberica, S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2011.