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Not yet recruiting NCT07340957

Valid-B.Well BP25 Study

No phase Interventional Volunteers Study Focus: Blood Pressure Measures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood pressure measurement.
Who it may be relevant to
Registry conditions: Volunteers, Study Focus: Blood Pressure Measures. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • 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 [Time frame: Day 1]
Secondary outcome measures (6)
  • Agreement by Bland-Altman analysis [Time frame: Day 1]
  • Population characteristics- Age [Time frame: Day 1]
  • Population Characteristics - Sex [Time frame: day 1]
  • Population Characteristics- arm circumferences [Time frame: Day 1]
  • Population Characteristics- baseline blood pressure categories [Time frame: Day 1]
  • Observser agreement [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Age > 12 years
  • Signed Informed Consent

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07340957 · BWE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗