Accuracy check of HiCardi M350 blood pressure monitor against standard cuff method in adults
Official title: 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
Run by Yonsei University · NCT07622498 · Data updated 2026-11-12
This study tests whether the HiCardi M350 device can measure blood pressure as accurately as a traditional sphygmomanometer in adults at a single hospital.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07622498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 19 years and older at Severance Hospital, including those with hypertension whose medications have been stable for at least 4 weeks.
✕Probably not a fit
Individuals with arm circumferences over 42 cm or with unclear Korotkoff phase V identification may not benefit from the device evaluation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center, single-arm study enrolls up to 100 adults to compare blood pressure readings from the HiCardi M350 against auscultatory measurements in line with ISO 81060-2:2018. Participants include a range of pressures to meet distribution requirements, with a target of at least 255 valid paired measurements. After informed consent and screening, participants will undergo dual measurements with both devices to assess accuracy. The trial aims to determine if the HiCardi M350 provides measurements that are clinically acceptable compared with the reference method. Data will be analyzed to confirm device performance across the eligible population.
Why it matters
Potential benefit: If successful, the HiCardi M350 could offer reliable, cuff-based blood pressure readings in a convenient patient monitor format.
How similar studies have gone: Previous standards-based comparisons of cuffless or alternative BP devices have shown variable results; this trial seeks to confirm performance against a validated auscultatory method.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Severance Hospital
Seoul, Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Min Dong Sung, Professor
- Email: MDSUNG@yuhs.ac
- Phone: +82-10-6554-0827
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.