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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

1. juni 2026 oppdatert av: Yonsei University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Min Dong Sung, Professor
  • Telefonnummer: +82-10-6554-0827
  • E-post: MDSUNG@yuhs.ac

Studiesteder

  • Sør -Korea
    • Seoul
      • Seoul, Seoul, Sør -Korea, 03722
        • Rekruttering
        • Severance Hospital
        • Ta kontakt med:
          • Min Dong Sung, Professor
          • Telefonnummer: +82-10-6554-0827
          • E-post: MDSUNG@yuhs.ac

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference between systolic and diastolic blood pressure measurements obtained using HiCardi M350 and a reference auscultatory sphygmomanometer
Tidsramme: After completion of all participants' data collection (within approximately 7 months of enrollment period)
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yonsei University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

31. august 2026

Studiet fullført (Antatt)

31. august 2026

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 1-2026-0008

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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