Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03382691

Enrollment

100

Registered

2017-12-26

Start date

2016-12-31

Completion date

2017-01-31

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.

Interventions

DEVICEblood pressure check

Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Participants whose systolic blood pressure \<=110 should be at least 10% of whole cohort 2. Participants whose systolic blood pressure \>=160 should be at least 10% of whole cohort 3. Participants whose diastolic blood pressure \>=100 should be at least 10% of whole cohort 4. Participants whose diastolic blood pressure \<=70 should be at least 10% of whole cohort 5. Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort 6. Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort

Exclusion criteria

1. heart disease with abnormal rhythm 2. peripheral vascular anomaly or disease 3. inadequate to be applied blood pressure cuff (e.g. trauma on arm) 4. pregnant or lactating women

Design outcomes

Primary

Measure	Time frame	Description
mean difference of systolic blood pressure	1 day at visit 2	mean difference of blood pressure between new and control device
mean difference of diastolic blood pressure	1 day at visit 2	mean difference of diastolic blood pressure between new and control device
standard deviation of the difference of systolic blood pressure	1 day at visit 2	standard deviation of the difference of systolic blood pressure between new and control device
standard deviation of the difference of diastolic blood pressure	1 day at visit 2	standard deviation of the difference of diastolic blood pressure between new and control device

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026