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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: blood pressure check

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyenggi DO
    • Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL; Blood pressure check using mobile device and control device	Device: blood pressure check; Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SNUBH_GO_056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No