Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization

NACompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

July 21, 2021

Study Completion Date

July 23, 2021

Conditions
Blood Pressure
Interventions
DEVICE

Blood pressure measurement group

"In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type. The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device."

Trial Locations (1)

04763

Hanyang University Seoul Hospital, Seoul

All Listed Sponsors
collaborator

Bionet Co., Ltd

INDUSTRY

lead

Hoon-Ki Park

OTHER

NCT06609486 - Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization | Biotech Hunter | Biotech Hunter