Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382691
• Other study ID #: SNUBH_GO_056
• Status: Completed
• Phase: N/A
• First received: October 29, 2017
• Last updated: December 22, 2017
• Start date: December 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• blood pressure check
Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam Si	Gyenggi DO

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean difference of systolic blood pressure	mean difference of blood pressure between new and control device	1 day at visit 2
Primary	mean difference of diastolic blood pressure	mean difference of diastolic blood pressure between new and control device	1 day at visit 2
Primary	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
Primary	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