Status:
UNKNOWN
Validation of the Blood Pressure Monitoring Function
Lead Sponsor:
RadiRad Co., Ltd.
Collaborating Sponsors:
Hualien Tzu Chi General Hospital
Conditions:
Blood Pressure
Eligibility:
All Genders
20-99 years
Brief Summary
High blood pressure is a major risk factor for cardiovascular diseases, stroke, and kidney disorders. Accurate blood pressure monitoring is crucial for the diagnosis, treatment, and prevention of comp...
Detailed Description
Following the ISO 81060-2:2018 standard, the accuracy of RadiHeart will be evaluated by comparing the blood pressure values obtained by the device with those measured by a conventional mercury sphygmo...
Eligibility Criteria
Inclusion
- The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female. Additionally, they must meet the following blood pressure conditions:
- At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≥ 160 mmHg (21.33 kPa).
- At least 20% (17 individuals) of the participants should have reference systolic blood pressure readings ≥ 140 mmHg (18.66 kPa).
- At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≤ 100 mmHg (13.33 kPa).
- At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≤ 60 mmHg (8.0 kPa).
- At least 20% (17 individuals) of the participants should have reference diastolic blood pressure readings ≥ 85 mmHg (11.33 kPa).
- At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≥ 100 mmHg (13.33 kPa).
Exclusion
- Pregnant.
- Having any of the following conditions:
- Arrhythmia
- Medical assessment indicates that poor blood circulation would affect the blood pressure data collection.
- Involuntary hand movements that would affect the blood pressure data collector.
- Nail polish on the light sensor area of the fingertip oximeter.
- Other conditions as determined by a physician that make the individual unsuitable for participation in the trial.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06104501
Start Date
October 20 2023
End Date
May 31 2024
Last Update
October 27 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.