Wrist-Worn blood pressure monitor put to the test against gold standard
NCT ID NCT07713576
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This trial checks whether a wrist-worn blood pressure monitor (Model: RIV-B10) can measure blood pressure as accurately as the traditional arm cuff and mercury device. About 158 adults aged 18 and older with wrist sizes between 13 and 21 cm will have their blood pressure taken with both devices at rest, during daily activities, and after exercise. The goal is to see if the wrist monitor meets international accuracy standards for safe home use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Wrist ambulatory blood pressure monitor (Model: RIV-B10) compared to mercury sphygmomanometer
- What this could lead to
- If accurate, this wrist monitor could offer a convenient, portable way to track blood pressure throughout daily life.
- What could go wrong
- This is a device accuracy study, not a treatment trial. The monitor may not meet strict accuracy standards, especially during movement or exercise.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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158 people
The number who actually took part.
- Started
-
Apr 2026
- Finished
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Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
People over 18 years old
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily participate in this clinical trial and sign informed consent; 2. Subjects must be willing and able to comply with the study steps; 3. Subjects aged 18 and above with wrist circumferences of 13.0-21.0 cm. Exclusion Criteria: 1. Subjects whose ECG during the screening period showed severe arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, junctional tachycardia, sinus arrest, pathological sinoatrial node syndrome, pacemaker rhythm); 2. Subjects with sickle cell disease; 3. Subjects who have undergone previous mastectomy or arm lymph node resection; 4. Subjects allergic to nylon, fluor rubber, or hydrogenated nitrile rubber (HNBR); 5. Subjects with wounds on the limbs at the measurement site or inflammation in the wrist; 6. Subjects undergoing intravenous infusion, blood transfusion, or other catheter insertion at the measurement site of the limb; 7. Those who ate, drank alcohol, smoked, or exercised vigorously within 30 minutes prior to the study; 8. Subjects who have participated in other clinical investigations that may affect this trial within the past 30 days; 9. Investigator believe that subjects should not participate in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chenzhou First People's Hospital
Chenzhou, Hunan, 423000, China
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