N/A
N=120
Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
Bioelectrical Impedance Measurement of Healthy Adults
Bottom Line
View on ClinicalTrials.gov: NCT04030416 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: SMM — 0.34 kg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seca GmbH & Co. Kg.
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SMM |
0.34 | — |
| SECONDARY Phase Angle |
0.080 | — |
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.
Eligibility Criteria
Inclusion Criteria
- male and female subjects,
- 18 years and older,
- subjects need to be able to sign the informed consent and privacy policy
Exclusion Criteria
- acute disease
- pregnancy
- intake of diuretics
- edema diagnosed by inspection and palpation of lower limbs
- paralysis e.g. after a stroke
- neurodegenerative diseases e.g. ALS
- tumors in treatment
- amputation
- electronic implants e.g. pacemaker
- probands who cannot provide an ICF by themselves
- probands who might be dependent from the sponsor or the investigation site
- current alcohol abuse
- active prostheses
- electronic life-support systems, e.g. artificial heart, artificial lung
- portable electronic medical devices, e.g. ECG devices or infusion pumps
- metallic implants
Data sourced from ClinicalTrials.gov (NCT04030416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.