Trial Outcomes & Findings for Comparing Medical Body Composition Analyzer Seca mBCA 555 With Seca mBCA 515 (NCT NCT04030416)

Results Overview

Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

10min

Results posted on

2022-02-14

Participant Flow

Subjects were recruited at the blood donor service of the Institute of Transfusion Medicine. All subjects needed to be suitable for blood donation according to "Hämotherapie-Richtlinien nach §§ 12 a und 18 TFG", chapter 2.1.4. Blood donation was conducted after study examinations.

Participant milestones

Participant milestones
Measure	Healthy Blood Donors single arm study with healthy blood donors
Overall Study STARTED	120
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No valid measurement is available for ID 113, resulting in 119 valid measurements

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Blood Donors n=119 Participants single arm study with healthy blood donors
Age, Continuous	40.0 years STANDARD_DEVIATION 13.6 • n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
Sex: Female, Male Female	57 Participants n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
Sex: Female, Male Male	62 Participants n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
Ethnicity (NIH/OMB) Unknown or Not Reported	119 Participants n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements
weight	78.0 kg STANDARD_DEVIATION 14.8 • n=5 Participants • No valid measurement is available for ID 113, resulting in 119 valid measurements

PRIMARY outcome

Timeframe: 10min

Population: healthy blood donors

Skeletal muscle mass, bias of mBCA 555 in comparison to mBCA 515

Outcome measures

Outcome measures
Measure	Healthy Blood Donors n=119 Participants single arm study with healthy blood donors
SMM	0.34 kg Standard Deviation 0.44

SECONDARY outcome

Timeframe: 10 minutes

Population: healthy blood donors

Phase angle at 50 kHz, bias of mBCA 555 in comparison to mBCA 515

Outcome measures

Outcome measures
Measure	Healthy Blood Donors n=119 Participants single arm study with healthy blood donors
Phase Angle	0.080 Degree Standard Error 0.079

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes

resistance right body side, 50 kHz, bias of mBCA 555 in comparison to mBCA 515

Outcome measures

Outcome measures
Measure	Healthy Blood Donors n=119 Participants single arm study with healthy blood donors
R50RS	-1.9 Ohm Standard Deviation 5.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes

resistance right body side, 5 kHz, bias of mBCA 555 in comparison to mBCA 515

Outcome measures

Outcome measures
Measure	Healthy Blood Donors n=119 Participants single arm study with healthy blood donors
R5RS	-3.05 Ohm Standard Deviation 6.12

Adverse Events

Single Arm Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristin Klückmann

seca gmbh & co. kg

Phone: +49(40)200000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place