Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00956917
Status:
COMPLETED
Last Update Posted:
2009-08-11
First Post:
2009-08-08
Brief Title:
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition
Sponsor:
Akern USA LLC
Organization:
Akern USA LLC
Study Overview
Official Title:
Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the ElectroFluidGraphtm EFG impedance analyzer is comparable to a predicate device in measuring human body composition
Detailed Description:
The purpose of this study is to determine if the ElectroFluidGraphtm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None