Bioelectrical Impedance Measurement of Healthy AdultsNCT04030416
Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
An observational study of Bioelectrical Impedance Measurement of Healthy Adults, run by Seca GmbH & Co. Kg. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bioelectrical Impedance Measurement of Healthy Adults
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: healthy adults
Who may be able to join
- male and female subjects,
- 18 years and older,
- subjects need to be able to sign the informed consent and privacy policy
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf - Institute of Transfusion Medicine
Hamburg, 20246
About this study
Official title: Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515
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.
Read the 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.
- Keywords
- mBCA 555
What is being measured
The primary outcome is the main question the study is designed to answer.
SMM
Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515
Measured: 10min
Secondary outcomes (1)
Phase Angle
Phase angle at 50 kHz, bias of mBCA 555 in comparison to mBCA 515
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Jun 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bioelectrical Impedance Measurement of Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seca GmbH & Co. Kg.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Peine, Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030416
- Sponsor's protocol ID
- BCA-21
- Status last verified
- Oct 2021
- First submitted
- 19 Jul 2019
- Last updated
- 14 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515
- ClinicalTrials.gov ID
- NCT04030416
- Acronym / sponsor ID
- BCA-21
- Keywords
- mBCA 555
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seca GmbH & Co. Kg.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Posted 14 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- healthy adults
Key inclusion criteria (3 listed)
- male and female subjects,
- 18 years and older,
- subjects need to be able to sign the informed consent and privacy policy
Key exclusion criteria (16 listed)
- acute disease
- pregnancy
- intake of diuretics
- edema diagnosed by inspection and palpation of lower limbs
- paralysis e.g. after a stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SMM
Time frame: 10min
Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515
1 secondary outcome
Phase Angle
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Peine, Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioelectrical Impedance Measurement of Healthy Adults, run by Seca GmbH & Co. Kg. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMM (time frame: 10min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.