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Not yet recruitingNCT06104501Updated Oct 27, 2023

Validation of the Blood Pressure Monitoring Function

An observational study in Blood Pressure, sponsored by RadiRad Co., Ltd.. Not yet recruiting. Open to participants aged 20 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-27.

Sponsored by RadiRad Co., Ltd. · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
20 Years to 99 Years
Sex
All
01

Study 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 complications related to high blood pressure. In recent years, due to the rapid development of wearable devices and mobile technology, wearable blood pressure monitors have gradually become a non-invasive and convenient method for blood pressure monitoring. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiHeart (an application program) in blood pressure measurement.

Read the 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 sphygmomanometer. This research is expected to recruit 170 adults aged 20 and above. All participants will undergo blood pressure measurements using both RadiHeart and a mercury sphygmomanometer. Participants will operate RadiHeart under the guidance of the testing personnel, while the mercury sphygmomanometer will be operated by trained healthcare professionals. The blood pressure measurement results from both devices will be recorded simultaneously, and the consistency between the blood pressure values measured by RadiHeart and the traditional mercury sphygmomanometer will be compared to validate the accuracy of the blood pressure application.

02

Conditions studied

  • Blood Pressure

Keywords

  • Artificial Intelligence(AI) Algorithm
  • blood pressure
03

In context

Lead sponsor

RadiRad Co., Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This trial expects to enroll 170 participants. 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

  1. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≥ 160 mmHg (21.33 kPa).
  2. At least 20% (17 individuals) of the participants should have reference systolic blood pressure readings ≥ 140 mmHg (18.66 kPa).
  3. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≤ 100 mmHg (13.33 kPa).
  4. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≤ 60 mmHg (8.0 kPa).
  5. At least 20% (17 individuals) of the participants should have reference diastolic blood pressure readings ≥ 85 mmHg (11.33 kPa).
  6. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≥ 100 mmHg (13.33 kPa).

Exclusion criteria

Exclusion Criteria:

  1. Pregnant.

  2. 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (estimated)
Patient registry
No

Interventions

  • DeviceRadiHeart

    The participants' blood pressure will be measured multiple times by both the mercury sphygmomanometer and RadiHeart, by using the same arm sequential method.

06

What researchers measure

Primary outcomes

  1. Difference in blood pressure (mean)

    The mean value of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be within or equal to ±5.0 mmHg.

    Time frame: 1 hour per individual

  2. Difference in blood pressure (standard deviation)

    The standard deviation of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be no greater than 8.0 mmHg.

    Time frame: 1 hour per individual

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06104501
Lead sponsor
RadiRad Co., Ltd.
Collaborators
Hualien Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Oct 27, 2023
Start date
Oct 20, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Oct 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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