Valid-B.Well BP25 Study

B.Well Swiss AG

Status: Not yet enrolling

Conditions: Volunteers; Study Focus: Blood Pressure Measures

Treatments: Diagnostic Test: Blood pressure measurement

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07340957

BWE-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Sigle arm

Experimental group

Description:

Single-arm. All subjects will undergo blood pressure measurement with the reference manual method and with upper arm automated sphygmomanometer (3 times each).

Treatment:

Diagnostic Test: Blood pressure measurement