NCT00956917

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

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

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

August 8, 2009

Last Update Submit

August 10, 2009

Conditions

Body Composition Measurement

Outcome Measures

Primary Outcomes (1)

  • Resistance (R) - (ohms)

    5 minutes

Secondary Outcomes (4)

  • Fat Free Mass (FFM)

    5 minutes

  • Total Body Water (TBW)

    5 minutes

  • Extra Cellular Water

    5 minutes

  • Fat Mass (FM)

    5 minutes

Study Arms (2)

Akern EFG

ACTIVE COMPARATOR
Device: Akern USA EFG

RJL device

ACTIVE COMPARATOR
Device: RJL Impedance analyzer

Interventions

Akern USA EFGDEVICE

Impedance measurement device

Akern EFG
RJL Impedance analyzerDEVICE

Impedance analyzer

RJL device

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio, FIGC, Settore Tecnico Coverciano

D'Annunzio, Florence, 50135, Italy

Location

Study Officials

  • Luca Gatteschi, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2009

First Posted

August 11, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

IT(1)