Blood PressureNCT06815614
This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022
An observational study of Blood Pressure and Blood Pressure Variability, run by Taiwan Biophotonic Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Blood Pressure, Blood Pressure Variability
- What is being tested?
- A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Nov 2023to 26 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in the National Taiwan University Hospital Hsin-Chu Branch. A total of 30~40 patients are intended to be recruited.
Who may be able to join
- Subject must be over 22 years old on the date of informed consent.
- Subject who has undergone radial artery cannulation (A-line) (for medical purposes, specifically for arterial pressure monitoring.
- Subject or his/her legal representative understand the written informed consent and willing to participate as evidenced by signing the informed consent.
Who cannot join
- Pregnancy
- Patients with an intra-aortic balloon pump
- Patients with arm or finger injuries
- Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
- Patients with A-line placement in the brachial artery
- Participants are considered not suitable for inclusion after evaluation by the researchers (such as poor compliant mental status or health conditions, etc.)
- Participants or his/her legal representative refuse to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 30059
About this study
Official title: A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer: Performance Evaluation in Stability and Blood Pressure Change Tracking
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.
Read the detailed description
- The primary goal (Stability Test): to validate the stability of the repeated measurements of DUE, and the corrected standard deviation of each analysis period shall not exceed 6 mmHg.
- The secondary goal (Blood Pressure Change Tracking): to validate the consistency of DUE vs. the reference BPM equipment in blood pressure change tracking during the change evaluation interval.
- Conditions
- Blood Pressure, Blood Pressure Variability
- Being tested
- A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer
- Keywords
- ISO 81060-3:2022, Photoplethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Photoplethysmography-Based Continuous Automated Non-Invasive SphygmomanometerDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
Measured: 4 hours
Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start29 Nov 2023
- Primary completion19 Sep 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Biophotonic Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815614
- Sponsor's protocol ID
- tBPC-BP-202309072DS
- Status last verified
- Nov 2024
- First submitted
- 12 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer: Performance Evaluation in Stability and Blood Pressure Change Tracking
- ClinicalTrials.gov ID
- NCT06815614
- Acronym / sponsor ID
- tBPC-BP-202309072DS
- Conditions
- Blood Pressure, Blood Pressure Variability
- Keywords
- ISO 81060-3:2022, Photoplethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taiwan Biophotonic CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- The primary goal (Stability Test): to validate the stability of the repeated measurements of DUE, and the corrected standard deviation of each analysis period shall not exceed 6 mmHg.
- The secondary goal (Blood Pressure Change Tracking): to validate the consistency of DUE vs. the reference BPM equipment in blood pressure change tracking during the change evaluation interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in the National Taiwan University Hospital Hsin-Chu Branch. A total of 30~40 patients are intended to be recruited.
Key inclusion criteria (3 listed)
- Subject must be over 22 years old on the date of informed consent.
- Subject who has undergone radial artery cannulation (A-line) (for medical purposes, specifically for arterial pressure monitoring.
- Subject or his/her legal representative understand the written informed consent and willing to participate as evidenced by signing the informed consent.
Key exclusion criteria (7 listed)
- Pregnancy
- Patients with an intra-aortic balloon pump
- Patients with arm or finger injuries
- Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
- Patients with A-line placement in the brachial artery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Photoplethysmography-Based Continuous Automated Non-Invasive SphygmomanometerThe 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. | Device | – |
Primary outcome
Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
Time frame: 4 hours
Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Blood Pressure Variability, run by Taiwan Biophotonic Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.