Body Composition MeasurementNCT00956917
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition
A study testing Akern USA EFG and RJL Impedance analyzer in people with Body Composition Measurement, run by Akern USA LLC at 1 site in Italy.
Trial summary
The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition Measurement
- What is being tested?
- Akern USA EFG and RJL Impedance analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Jun 2009
- Phase
- Interventional
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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy individuals
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
Laboratorio, FIGC, Settore Tecnico Coverciano
D'Annunzio, Florence, 50135
About this study
Official title: Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems
The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.
Read the detailed description
The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates [total body water (TBW); fat-free mass (FFM); and fat mass (FM)] calculated by using the same prediction equation (models) as the predicate device.
- Conditions
- Body Composition Measurement
- Being tested
- Akern USA EFG, RJL Impedance analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akern USA EFGDevice
Impedance measurement device
RJL Impedance analyzerDevice
Impedance analyzer
| Study group | Role | What they receive |
|---|---|---|
| Akern EFG | Active comparator | Not described Receives: Device: Akern USA EFG |
| RJL device | Active comparator | Not described Receives: Device: RJL Impedance analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance (R) - (ohms)
Measured: 5 minutes
Secondary outcomes (4)
Fat Free Mass (FFM)
Measured: 5 minutes
Total Body Water (TBW)
Measured: 5 minutes
Extra Cellular Water
Measured: 5 minutes
Fat Mass (FM)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition MeasurementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akern USA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luca Gatteschi, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956917
- Sponsor's protocol ID
- EFG001
- Status last verified
- Aug 2009
- First submitted
- 8 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No