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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Min Dong Sung, Professor
- Numéro de téléphone: +82-10-6554-0827
- E-mail: MDSUNG@yuhs.ac
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 03722
- Recrutement
- Severance Hospital
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Contact:
- Min Dong Sung, Professor
- Numéro de téléphone: +82-10-6554-0827
- E-mail: MDSUNG@yuhs.ac
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 19 years or older.
- Individuals who visit Severance Hospital and voluntarily provide written informed consent after receiving and understanding sufficient explanation of the study.
- 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:
- Individuals in whom Korotkoff phase V cannot be clearly identified during auscultatory blood pressure measurement.
- Individuals for whom blood pressure measurement is difficult or expected to be difficult.
- Individuals with bilateral arm circumference greater than 42 cm.
- Pregnant women.
- Individuals currently participating in another clinical trial or who have participated in another clinical trial within 30 days before the screening date.
- Individuals judged by the investigator to be inappropriate for participation in the clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference between systolic and diastolic blood pressure measurements obtained using HiCardi M350 and a reference auscultatory sphygmomanometer
Délai: After completion of all participants' data collection (within approximately 7 months of enrollment period)
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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.
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After completion of all participants' data collection (within approximately 7 months of enrollment period)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1-2026-0008
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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