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出境医 / 临床实验 / Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Sven Peine, Dr. Universitätsklinikum Hamburg-Eppendorf
Tracking Information
First Submitted Date July 19, 2019
First Posted Date July 24, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date June 20, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2019)
  • BIA 5 and 50 kHz [ Time Frame: 10 minutes ]
    Bioelectrical Impedance of 5 and 50 kHz for one body side
  • BIA 50 kHz [ Time Frame: 10 minutes ]
    Bioelectrical Impedance of 50 kHz for all 4 extremities
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 19, 2019) 		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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515
Official Title Clinical Accuracy Validation of the Medical Body Composition Analyzer Seca mBCA 555 in Comparison to Seca mBCA 515
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population healthy adults
Condition Bioelectrical Impedance Measurement of Healthy Adults
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2019) 		120
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Kristin Klückmann +4940200000 ext 232 Kristin.Klueckmann@seca.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04030416
Other Study ID Numbers BCA-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Seca GmbH & Co. Kg.
Study Sponsor Seca GmbH & Co. Kg.
Collaborators Not Provided
Investigators
Principal Investigator: Sven Peine, Dr. Universitätsklinikum Hamburg-Eppendorf
PRS Account Seca GmbH & Co. Kg.
Verification Date July 2019

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