Status:
COMPLETED
Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization
Lead Sponsor:
Hoon-Ki Park
Collaborating Sponsors:
Bionet Co., Ltd
Conditions:
Blood Pressure
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermi...
Eligibility Criteria
Inclusion
- Recruitment is made through the recruitment notice for patients and their guardians who visit Hanyang University Hospital. Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements are recruited.
Exclusion
- Emergency surgery patient
- Persons who have mental disorders such as mental retardation, autism, etc. and who have difficulty measuring blood pressure or are expected to have difficulties
- A person who disagreed with the study
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2021
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06609486
Start Date
June 1 2020
End Date
July 23 2021
Last Update
March 3 2025
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, South Korea, 04763