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

NCT04030416 | Completed Results

• 1 other identifier: BCA-21
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioelectrical Impedance Measurement of Healthy Adults

Keywords

mBCA 555

Outcome Measures

Primary Outcomes (1)

• SMM

  Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515

  10min

Secondary Outcomes (1)

• Phase Angle

  10 minutes

Other Outcomes (2)

• R50RS

  5 minutes

• R5RS

  5 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy adults

You may qualify if:

• male and female subjects,
• years and older,
• subjects need to be able to sign the informed consent and privacy policy

You may not qualify if:

• 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

Sponsors & Collaborators

• Seca GmbH & Co. Kg.: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine

Hamburg, 20246, Germany

Location

Results Point of Contact

• Title: Kristin Klückmann
• Organization: seca gmbh & co. kg

kristin.klueckmann@seca.com

+49(40)200000

Study Officials

• Sven Peine, Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 24, 2019
• Study Start: June 20, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 14, 2022
• Results First Posted: February 14, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)