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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 29, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedDecember 26, 2017
October 1, 2017
1 month
October 29, 2017
December 22, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
EXPERIMENTAL
EXPERIMENTALBlood pressure check using mobile device and control device
Interventions
Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, 463707, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2017
First Posted
December 26, 2017
Study Start
December 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
December 26, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share