Blood PressureNCT06609486

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

A study testing Blood pressure measurement group in people with Blood Pressure, run by Hoon-Ki Park at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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.… Read more about this study

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: Blood pressure measurement group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteSouth Korea
Study dates: 1 Jun 2020to 23 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Hanyang University Seoul Hospital
Seoul, 04763

Other trials in South Korea

About this study

Official title: Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol

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
Being tested: Blood pressure measurement group
Keywords: Hypotension, Hypertension, Prehypertension, Sphygmomanometers
Medical subject headings: Hypotension, Hypertension, Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood pressure measurement groupDevice
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.

Study groups in NCT06609486
Study group	Role	What they receive
Blood pressure measurement group	Experimental	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. Receives: Device: Blood pressure measurement group

What is being measured

The primary outcome is the main question the study is designed to answer.

Test Device's Blood Pressure of Resting Condition
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 BP 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.
Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less.
Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively.
Measured: Right after the experiment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202023 Jul 2021

First posted24 Sep 2024
Study start1 Jun 2020
Primary completion21 Jul 2021
Study completion23 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06609486
Sponsor's protocol ID: HKPark
Status last verified: Feb 2025
First submitted: 20 Sep 2024
Last updated: 3 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alpert BS. Validation of the Welch Allyn Spot Vital Signs blood pressure device according to the ANSI/AAMI SP10: 2002. Accuracy and cost-efficiency successfully combined. Blood Press Monit. 2007 Oct;12(5):345-7. doi: 10.1097/MBP.0b013e3282c9abf7.
PubMed 17890975
Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. doi: 10.1097/01.mbp.0000189788.05736.5f.
PubMed 16410738
Guidelines for Accuracy Evaluation of Electronic Sphygmomanometers - KFDA Food and Drug Administration
O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010 Feb;15(1):23-38. doi: 10.1097/MBP.0b013e3283360e98. No abstract available.
PubMed 20110786
Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens. 2018 Mar;36(3):472-478. doi: 10.1097/HJH.0000000000001634.
PubMed 29384983
International Organization for Standardization. Noninvasive sphygmomanometers: part 2: clinical investigation of intermittent automated measurement type. (2018): 36.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol
ClinicalTrials.gov ID: NCT06609486
Acronym / sponsor ID: HKPark
Conditions: Blood Pressure
Keywords: Hypotension, Hypertension, Prehypertension, Sphygmomanometers
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Hoon-Ki ParkUniversity, hospital or other
Collaborators: Bionet Co., Ltd
Study start: 1 Jun 2020 (actual)
Primary completion: 21 Jul 2021 (actual)
Study completion: 23 Jul 2021 (actual)
First posted: 24 Sep 2024 (actual)
Results: Posted 3 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Blood pressure measurement group	Experimental	Device: Blood pressure measurement groupIn 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.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood pressure measurement groupIn 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.	Device	Blood pressure measurement group

Primary outcome

Test Device's Blood Pressure of Resting Condition
Time frame: Right after the experiment
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 BP 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. Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less. Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively.

Results and safety

Results posted to the registry on 3 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blood Pressure Measurement Group	86	86

Primary outcome: Test Device's Blood Pressure of Resting Condition

Time frame: Right after the experiment. Mean (Standard Deviation). Unit: mmHg

Measure	Blood Pressure Measurement Group n = 86
Criterion 1 (SBP)	-1.55 (6.25)
Criterion 1 (DBP)	-0.02 (6.61)
Criterion 2 (SBP)	-1.6 (4.97)
Criterion 2 (DBP)	-0.0 (5.82)

Population analysed: A total of 86 study subjects were enrolled. 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, and a total of 258 data pairs were obtained. Among them, some data of three study subjects did not satisfy the conditions required by ISO 81060-2:2018, so one dropout data pair (total of three dropout data pairs) occurred. Therefore, 255 valid data pairs were obtained from 86 study subjects.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blood Pressure Measurement Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17890975Alpert BS. Validation of the Welch Allyn Spot Vital Signs blood pressure device according to the ANSI/AAMI SP10: 2002. Accuracy and cost-efficiency successfully combined. Blood Press Monit. 2007 Oct;12(5):345-7. doi: 10.1097/MBP.0b013e3282c9abf7.
Background: PubMed 16410738Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. doi: 10.1097/01.mbp.0000189788.05736.5f.
BackgroundGuidelines for Accuracy Evaluation of Electronic Sphygmomanometers - KFDA Food and Drug Administration
Background: PubMed 20110786O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010 Feb;15(1):23-38. doi: 10.1097/MBP.0b013e3283360e98. No abstract available.
Background: PubMed 29384983Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens. 2018 Mar;36(3):472-478. doi: 10.1097/HJH.0000000000001634.
BackgroundInternational Organization for Standardization. Noninvasive sphygmomanometers: part 2: clinical investigation of intermittent automated measurement type. (2018): 36.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hoon-Ki Park, M.D., Ph.D. principal investigator

Department of Family Medicine, Hanyang University Seoul Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood pressure measurement group in people with Blood Pressure, run by Hoon-Ki Park at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test Device's Blood Pressure of Resting Condition (time frame: Right after the experiment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06609486, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.