Status:
COMPLETED
Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Blood Pressure
Eligibility:
All Genders
20+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Participants whose systolic blood pressure \<=110 should be at least 10% of whole cohort
- Participants whose systolic blood pressure \>=160 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure \>=100 should be at least 10% of whole cohort
- Participants whose diastolic blood pressure \<=70 should be at least 10% of whole cohort
- Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
- Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort
Exclusion
- heart disease with abnormal rhythm
- peripheral vascular anomaly or disease
- inadequate to be applied blood pressure cuff (e.g. trauma on arm)
- pregnant or lactating women
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03382691
Start Date
December 1 2016
End Date
January 1 2017
Last Update
December 26 2017
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, South Korea, 463707