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Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

NCT ID: NCT03382691

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EXPERIMENTAL

Blood pressure check using mobile device and control device

Group Type EXPERIMENTAL

blood pressure check

Intervention Type DEVICE

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

Interventions

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blood pressure check

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH_GO_056

Identifier Type: -

Identifier Source: org_study_id