Status:
COMPLETED
Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
Lead Sponsor:
Seca GmbH & Co. Kg.
Conditions:
Bioelectrical Impedance Measurement of Healthy Adults
Eligibility:
All Genders
18+ years
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 calculati...
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...
Eligibility Criteria
Inclusion
- male and female subjects,
- 18 years and older,
- subjects need to be able to sign the informed consent and privacy policy
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04030416
Start Date
June 20 2019
End Date
July 31 2019
Last Update
February 14 2022
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine
Hamburg, Germany, 20246