Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382691
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: blood pressure check Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. mean difference of systolic blood pressure [ Time Frame: 1 day at visit 2 ]
    mean difference of blood pressure between new and control device

  2. mean difference of diastolic blood pressure [ Time Frame: 1 day at visit 2 ]
    mean difference of diastolic blood pressure between new and control device

  3. standard deviation of the difference of systolic blood pressure [ Time Frame: 1 day at visit 2 ]
    standard deviation of the difference of systolic blood pressure between new and control device

  4. standard deviation of the difference of diastolic blood pressure [ Time Frame: 1 day at visit 2 ]
    standard deviation of the difference of diastolic blood pressure between new and control device


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382691


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03382691    
Other Study ID Numbers: SNUBH_GO_056
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No