N/A N=86 Diagnostic

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

Blood Pressure

Bottom Line

View on ClinicalTrials.gov: NCT06609486 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2025

Primary outcome: Primary: Test Device's Blood Pressure of Resting Condition — -1.55; -0.02; -1.6; -0.0 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood pressure measurement group (Device)
Age: Pediatric, Adult, Older Adult · 3+ yrs
Sex: All
Sponsor: Hoon-Ki Park
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Test Device's Blood Pressure of Resting Condition	-1.55; -0.02; -1.6; -0.0	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT06609486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.