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

NCT06815614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Blood Pressure
  • Blood Pressure Variability

Interventions

DEVICE

A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer

The investigation medical device under evaluation is oCareTM BP 100, a non-invasive continuous blood pressure monitoring system developed by Taiwan Biophotonic Co. (tBPC). The main function is to use a fingerclip sensor to receive PPG signals and collect continuous blood pressure values and uninterruptedly within the initialization time. 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 BP 100 start-to-end blood pressure calibration. The A-line invasive arterial catheter blood pressure measurement will be used as a reference invasive BPM equipment. The purpose of the study is to confirm the stability of the investigational medical device under evaluation and its performance of blood pressure change tracking.

Sponsors & Collaborators

  • Taiwan Biophotonic Corporation

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-09-19
Completion
2024-11-26

Countries

  • Taiwan

Study Locations

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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 NCT06815614 on ClinicalTrials.gov