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NCT06815614

This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022

Completed Last updated 7 February 2025
What this trial tests

trial testing A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer in Blood Pressure in 40 participants. Completed in 26 November 2024.

Timeline
29 November 2023
Primary endpoint
19 September 2024
26 November 2024

Quick facts

Lead sponsorTaiwan Biophotonic Corporation
StatusCompleted
Study typeOBSERVATIONAL
Enrollment40
Start date29 November 2023
Primary completion19 September 2024
Estimated completion26 November 2024
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Taiwan Biophotonic Corporation

Who can join

22 and older, any sex, with Blood Pressure or Blood Pressure Variability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP100 start-to-end blood pressure calibration. The invasive arterial catheter (A-line) blood pressure measurement will be used as a reference invasive blood pressure monitor (BPM) equipment. The purpose of the study is to evaluate the stability of the device under evaluation (DUE) and its performance in blood pressure change tracking.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06815614.

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