Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515

Completed

Conditions: Bioelectrical Impedance Measurement of Healthy Adults

Registration Number: NCT04030416

Lead Sponsor: Seca GmbH & Co. Kg.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SMM	10min	Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515

Secondary Outcome Measures

Name	Time	Method
Phase Angle	10 minutes	Phase angle at 50 kHz, bias of mBCA 555 in comparison to mBCA 515

Trial Locations

Locations (1): University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine
🇩🇪
Hamburg, Germany
University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine
🇩🇪Hamburg, Germany