Valid-B.Well BP25 Study

NCT ID: NCT07340957

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-03-31

Brief Summary

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.

Conditions

Volunteers; Study Focus: Blood Pressure Measures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sigle arm

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

Group Type: EXPERIMENTAL

Blood pressure measurement

Intervention Type: DIAGNOSTIC_TEST

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 avoid talking during the entire measurement procedure.
• BP shall be measured on the subject's left arm at heart level.
• A minimum of 5 minutes shall elapse prior to obtaining the first reference blood pressure measurement.

Interventions

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 avoid talking during the entire measurement procedure.
• BP shall be measured on the subject's left arm at heart level.
• A minimum of 5 minutes shall elapse prior to obtaining the first reference blood pressure measurement.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

B.Well Swiss AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Thomas Fassler Fassler

Role: CONTACT

thomas.faessler@bwell-swiss.ch

+41 79 309 93 79

Other Identifiers

BWE-01

Identifier Type: -

Identifier Source: org_study_id