The Purpose of This Clinical Trial is to Evaluate the Accuracy of Blood Pressure Measurement of HiCardi M350 Compared to Blood Pressure Measured by Auscultatory Sphygmomanometer in Adult Volunteers (Including Those Meeting Blood Pressure Distribution Requirements) in Accordance With ISO 81060-2:2018

A Prospective, Single-center, Single-arm, Pivotal Clinical Trial to Evaluate the Accuracy of Blood Pressure Measurements From the HiCardi M350(Patient Monitor) in Comparison With Those Measured Using an Auscultatory Sphygmomanometer

This prospective, single-center, single-arm pivotal clinical trial is designed to evaluate the accuracy of blood pressure measurements obtained using the HiCardi M350 patient monitor compared with measurements obtained using an auscultatory sphygmomanometer.

The study will enroll adult volunteers aged 19 years or older, including participants needed to satisfy the blood pressure distribution requirements of ISO 81060-2:2018. The planned enrollment is 100 participants, considering the ISO 81060-2:2018 minimum requirement of 85 participants and an estimated dropout rate of approximately 15%. The study is also designed to obtain at least 255 valid paired blood pressure values.

After written informed consent, participants will undergo screening assessments, including demographics, vital signs, medical and surgical history, prior and concomitant medications, pregnancy testing for women of childbearing potential, bilateral arm circumference measurement, eligibility assessment, and adverse event assessment. On the blood pressure test day, eligibility will be reconfirmed, an enrollment number will be assigned, HiCardi M350 calibration will be performed, and blood pressure measurements will be obtained using both HiCardi M350 and the reference auscultatory method.

The primary effectiveness endpoint is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference sphygmomanometer under resting conditions. Accuracy will be evaluated according to ISO 81060-2:2018 using Criteria 1 and Criteria 2. Safety will be evaluated based on adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated adverse device effects, and device deficiencies.

Study Overview

• Status: Recruiting
• Conditions: No Restriction on Disease
• Intervention / Treatment: Device: HiCardi M350

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Dong Sung, Professor; Phone Number: +82-10-6554-0827; Email: MDSUNG@yuhs.ac

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 03722
      • Recruiting
      • Severance Hospital
      • Contact: Min Dong Sung, Professor; Phone Number: +82-10-6554-0827; Email: MDSUNG@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adults aged 19 years or older.
2. Individuals who visit Severance Hospital and voluntarily provide written informed consent after receiving and understanding sufficient explanation of the study.
3. Individuals with hypertension-range blood pressure may be included to meet the blood pressure distribution requirements. Participants receiving antihypertensive medication may be included only if the type and dose of medication have remained stable for at least 4 weeks before screening. Individuals with dose changes, medication additions, or medication discontinuation within 4 weeks before screening will be excluded.

Exclusion Criteria:

1. Individuals in whom Korotkoff phase V cannot be clearly identified during auscultatory blood pressure measurement.
2. Individuals for whom blood pressure measurement is difficult or expected to be difficult.
3. Individuals with bilateral arm circumference greater than 42 cm.
4. Pregnant women.
5. Individuals currently participating in another clinical trial or who have participated in another clinical trial within 30 days before the screening date.
6. Individuals judged by the investigator to be inappropriate for participation in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HiCardi M350; Participants will undergo blood pressure measurement using the investigational device, HiCardi M350, and the reference auscultatory sphygmomanometer. HiCardi M350 will be attached and calibrated according to the predefined procedure. Systolic and diastolic blood pressure values measured by HiCardi M350 will be compared with reference values measured by two independent observers using the auscultatory method.

Device: HiCardi M350; HiCardi M350 is a wearable patient monitoring device used to measure systolic and diastolic blood pressure. In this study, the device will be attached to each participant and calibrated according to the predefined procedure. Blood pressure values measured by HiCardi M350 will be compared with reference values obtained using an auscultatory sphygmomanometer and mechanical stethoscope by two independent observers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between systolic and diastolic blood pressure measurements obtained using HiCardi M350 and a reference auscultatory sphygmomanometer	The primary outcome is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference auscultatory sphygmomanometer under resting conditions. Accuracy will be assessed separately for systolic and diastolic blood pressure according to ISO 81060-2:2018 Criteria 1 and Criteria 2.	After completion of all participants' data collection (within approximately 7 months of enrollment period)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Blood Pressure; HiCardi M350
• Other Study ID Numbers: 1-2026-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No