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

NCT06609486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-03

Study results available
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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 intermittent automated measurement type) for BN1 (BNiBP), an electronic sphygmomanometer module newly developed by Bionet Co., Ltd., the clinical group and evaluation criteria presented in, the effectiveness of blood pressure measurement performance was evaluated.

The auscultation method used as a reference (gold standard) of a non-invasive blood pressure (NIBP) measurement method was used. The first blood pressure measurement was performed once each (reference BP not used for evaluation, R0; test BP not used for evaluation, T0) with auscultation and the test medical device (BM5 equipped with BN1 (BNiBP)). The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each blood pressure measurement.

Three data pairs (mean value of R1, R2 \& T1 / R2, mean value of R3 \& T2 / R3, mean value of R4 \& T3) were obtained from one study subject. This study aims to verify that the mean value of the differences and standard deviations of data pairs meet the criteria of ISO 81060-2:2018.

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.

Sponsors & Collaborators

  • Bionet Co., Ltd

    collaborator INDUSTRY

  • Hoon-Ki Park

    lead OTHER

Principal Investigators

  • Hoon-Ki Park, M.D., Ph.D. · Department of Family Medicine, Hanyang University Seoul Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-07-21
Completion
2021-07-23

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06609486 on ClinicalTrials.gov