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Valid-B.Well BP25 Study

NCT07340957 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-14

No results posted yet for this study

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

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 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.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • B.Well Swiss AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340957 on ClinicalTrials.gov