None listed
Conditions
Interventions
Medical Device : A static test was conducted in which Device A and a manual electronic sphygmomanometer were worn on the same arm of the subject and measurements were taken repeatedly at predetermined
Sponsors
Chung-Ang University Gwangmyeong Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting the following inclusion criteria will be selected using a simple random sampling method: (1) Male and female adults aged 19 to 65 years who are identified as having normotension, elevated blood pressure, hypertension, or hypotension based on clinical assessment. (2) Individuals who have been fully informed about the nature, purpose, procedures, potential risks and benefits of the clinical trial, have comprehended the information provided, and have voluntarily signed a written informed consent form agreeing to participate and comply with all study-related requirements
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in the study if they meet any of the following conditions: (1) Individuals who do not provide informed consent to participate in this study. (2) Pregnant women, children, elderly individuals, or those diagnosed with arrhythmia. (3) Any individuals who, in the judgment of the investigator, are deemed unsuitable for participation in this study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in blood pressure between the test device and the reference device | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard deviation in blood pressure between the test device and the reference device | — |
Countries
Korea, Republic of
Contacts
Public ContactHong Euy Lim
Chung-Ang University Gwangmyeong Hospital
Outcome results
None listed