Clinical trial NCT04030416: Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
Official title: Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioelectrical Impedance Measurement of Healthy Adults
Keywords: mBCA 555
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy adults

Brief 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.

Detailed description: The use of bioelectrical impedance analysis (BIA) is widespread both in healthy subjects and patients. BIA allows the determination of the fat-free mass (FFM), skeletal muscle mass (SMM), fat mass (FM), extracellular water (ECW) and total body water (TBW) when using appropriate population, age or pathology-specific BIA equations and established procedures. BIA equations are based on validation studies where BIA is compared with reference methods such as Air Displacement Plethysmography (ADP), Dual-Energy X-Ray Absorptiometry (DXA), Magnetic Resonance Imaging (MRI) and isotope dilution.

The predicate device seca mBCA 515 was compared to the gold standard methods MRI, DXA, ADP, D2O- and NaBr-dilution in previous clinical investigations in Kiel (Germany) and New York City (USA) 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 in a previous study conducted at the University Hospital Hamburg-Eppendorf.

The mBCA 555 is a new body composition analyzer measuring bioimpedance in standing position developed by seca.

Primary objective is to test whether the mBCA 515 prediction equations can be applied to the new mBCA 555. If necessary, to proof substantial equivalence, prediction equations should be adjusted for the mBCA 555.

Secondary objective is to compare Impedance, phase angle, reactance and resistance for different frequencies in order to clarify if normal ranges for BIVA and phase angle generated with the mBCA 515 need to be adjusted for the new mBCA 555.

Bioimpedance was measured using the seca mBCA 555 and mBCA 515. Body height was measured using the seca 274.

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

Primary outcomes:
measure: SMM
timeFrame: 10min
Secondary outcomes:
measure: Phase Angle
timeFrame: 10 minutes
Other outcomes:
measure: R50RS
timeFrame: 5 minutes
measure: R5RS
timeFrame: 5 minutes
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Sven Peine, Dr.
role: PRINCIPAL_INVESTIGATOR
References: