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ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04030416
NCT04030416N/ACompleted

Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515

Seca GmbH & Co. Kg.·observational·Posted Jul 24, 2019·Updated Feb 14, 2022

In Brief

An observational study for Bioelectrical Impedance Measurement of Healthy Adults. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations (BCA-01, BCA-02, BCA-20) to generate prediction equations for calculating body composition (FFM, SMM, ECW, TBW and VAT) in different populations. Furthermore, normal ranges for body composition were generated based on the previous study BCA-03 conducted at the UKE. The mBCA 555 is a new body composition analyzer measuring bioimpedance in standing position developed by seca. In order to apply prediction equations and normal ranges from previous clinical investigations BCA-01, BCA-02, BCA-03 and BCA-20 to the new mBCA 555 it shall be compared to the mBCA 515.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 24, 2019
Enrollment StartJun 20, 2019
Primary CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.9 years ago