Valid-B.Well BP25 Study

Официальное название

Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2

Обзор

Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard for the clinical validation of automated non-invasive sphygmomanometers (Non-invasive sphygmomano-meters - Part 2: Clinical investigation of intermittent automated measurement, including Amendments 1 and 2)). The validation will be conducted with volunteers rather than necessarily with patients, and all measurements will be performed outside of the subjects' normal diagnosis or treatment.

Вмешательства

• Диагностический тест Blood pressure measurement
  All measurements will be performed by trained observers in line with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard (1), ensuring accuracy, consistency, and reproducibility. The investigation shall be performed in an isolated room under comfortable ambient temperature. * The cuff shall be applied on the bare arm with no compression proximal to the cuff. * The subject shall rest quietly for at least 10 minutes prior to the start of measurements. * The subject should av

Первичные конечные точки

• The study will assess compliance with the following validation criteria defined by the standard ISO 81060-2:2018: Criterion 1 - Group-level accuracy (paired-difference analysis). Criterion 2 - Subject-level accuracy [Срок оценки: Day 1]

Вторичные конечные точки (6)

• Agreement by Bland-Altman analysis [Срок оценки: Day 1]
• Population characteristics- Age [Срок оценки: Day 1]
• Population Characteristics - Sex [Срок оценки: day 1]
• Population Characteristics- arm circumferences [Срок оценки: Day 1]
• Population Characteristics- baseline blood pressure categories [Срок оценки: Day 1]
• Observser agreement [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Age > 12 years
• Signed Informed Consent

Критерии исключения

• Any medical condition preventing light to moderate arm compression
• Absence of the upper arm
• Subjects with upper arm circumference <22 cm or >42 cm
• Subjects with severe shock;
• Subjects with a history of mental illness or current mental disorders;
• Patients with arrhythmias (atrial premature beats, ventricular premature beats, atrial fibrillation, etc.) or upper limb arteriosclerosis (at the direct measurement site);
• Subjects using extracorporeal circulation devices;
• Subjects with excessive limb asymmetry;
• Subjects who have undergone mastectomy or lymph node dissection;
• Subjects with arm injuries or exposed wounds, or those with circulatory disorders;
• Subjects with vascular accesses in the arms or arteriovenous shunt tubes;
• Subjects who have participated in other clinical trials within the past 1 month;
• Subjects for whom the procedures during the clinical trial may pose excessive medical risks;
• Subjects determined by the investigator to be unsuitable for participating in the clinical study.
• Subject under judicial protection, guardianship or curatorship or participant deprived of their liberty by judicial or administrative decision

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07340957 · BWE-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗