CompletedNot Applicable

Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.

China158 participantsStarted 2026-04-17

Plain-language summary

The accuracy and safety of the Wrist Ambulatory Blood Pressure Monitor (Model: RIV-B10) were assessed according to the requirements of ISO 81060-2:2018+AMD1:2020+AMD2:2024.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily participate in this clinical trial and sign informed consent;
. Subjects must be willing and able to comply with the study steps;
. Subjects aged 18 and above with wrist circumferences of 13.0-21.0 cm.

Exclusion criteria

. 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);
. Subjects with sickle cell disease;
. Subjects who have undergone previous mastectomy or arm lymph node resection;
. Subjects allergic to nylon, fluor rubber, or hydrogenated nitrile rubber (HNBR);
. Subjects with wounds on the limbs at the measurement site or inflammation in the wrist;
. Subjects undergoing intravenous infusion, blood transfusion, or other catheter insertion at the measurement site of the limb;
. Those who ate, drank alcohol, smoked, or exercised vigorously within 30 minutes prior to the study;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood pressure mean deviation and standard deviation- evaluation criterion 1

Timeframe: 30 minutes

Blood pressure mean deviation and standard deviation- evaluation criterion 2

Timeframe: 30 minutes

The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring

Timeframe: 30 minutes

The mean deviation and standard deviation of blood pressure measurements under exercise stress condition

Timeframe: 30 minutes

Trial details

NCT IDNCT07713576

SponsorHuawei Device Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-15

View on ClinicalTrials.gov More Blood Pressure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily participate in this clinical trial and sign informed consent;
. Subjects must be willing and able to comply with the study steps;
. Subjects aged 18 and above with wrist circumferences of 13.0-21.0 cm.

Exclusion criteria

. 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);
. Subjects with sickle cell disease;
. Subjects who have undergone previous mastectomy or arm lymph node resection;
. Subjects allergic to nylon, fluor rubber, or hydrogenated nitrile rubber (HNBR);
. Subjects with wounds on the limbs at the measurement site or inflammation in the wrist;
. Subjects undergoing intravenous infusion, blood transfusion, or other catheter insertion at the measurement site of the limb;
. Those who ate, drank alcohol, smoked, or exercised vigorously within 30 minutes prior to the study;

What they're measuring

Blood pressure mean deviation and standard deviation- evaluation criterion 1

Timeframe: 30 minutes

Blood pressure mean deviation and standard deviation- evaluation criterion 2

Timeframe: 30 minutes

The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring

Timeframe: 30 minutes

The mean deviation and standard deviation of blood pressure measurements under exercise stress condition

Timeframe: 30 minutes