Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
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|ClinicalTrials.gov Identifier: NCT01481285|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : October 4, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||992 participants|
|Official Title:||Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited.
- Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz [ Time Frame: about 15 minutes ]The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are planned to be measured.
- Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S. [ Time Frame: about 15 minutes ]Predicate Device: BIOSPACE INBODY 720
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): NCT01481285
|Institute for Transfusion Medicine|
|Hamburg, Germany, 20246|
|Principal Investigator:||Sven Peine, Dr.||Universitätsklinikum Hamburg-Eppendorf|