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

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ClinicalTrials.gov Identifier: NCT04030416
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Bioelectrical Impedance Measurement of Healthy Adults

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019



Primary Outcome Measures :
  1. BIA 5 and 50 kHz [ Time Frame: 10 minutes ]
    Bioelectrical Impedance of 5 and 50 kHz for one body side

  2. BIA 50 kHz [ Time Frame: 10 minutes ]
    Bioelectrical Impedance of 50 kHz for all 4 extremities


Secondary Outcome Measures :
  1. Complete BIA [ Time Frame: 10 minutes ]
    Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
healthy adults
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030416


Contacts
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Contact: Kristin Klückmann +4940200000 ext 232 Kristin.Klueckmann@seca.com

Locations
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Germany
Institute of Transfusion Medicine Recruiting
Hamburg, Germany, 20246
Contact: Sven Peine, Dr.       s.peine@uke.de   
Sponsors and Collaborators
Seca GmbH & Co. Kg.
Investigators
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Principal Investigator: Sven Peine, Dr. Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Seca GmbH & Co. Kg.
ClinicalTrials.gov Identifier: NCT04030416     History of Changes
Other Study ID Numbers: BCA-21
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No