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

NCT07713576 | Completed

• 1 other identifier: CTP-PPA0971CHN26013010610968
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (4)

• Blood pressure mean deviation and standard deviation- evaluation criterion 1

  The mean deviation and standard deviation between the blood pressure values measured by the investigational deviceand those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255). Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.

  30 minutes

• Blood pressure mean deviation and standard deviation- evaluation criterion 2

  The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85). Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceedthe maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020+AMD2:2024.

  30 minutes

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

  The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020+AMD2:2024 , specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.

  30 minutes

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

  The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020+AMD2:2024, specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.

  30 minutes

Study Arms (1)

Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer

Device: Wrist Ambulatory Blood Pressure Monitor/mercury sphygmomanometer

Interventions

Wrist Ambulatory Blood Pressure Monitor/mercury sphygmomanometer DEVICE

Wrist Ambulatory Blood Pressure Monitor Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People over 18 years old

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects who have participated in other clinical investigations that may affect this trial within the past 30 days;
• Investigator believe that subjects should not participate in this clinical trial.

Sponsors & Collaborators

• Huawei Device Co., Ltd: lead

Study Sites (1)

Chenzhou First People's Hospital

Chenzhou, Hunan, 423000, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: April 17, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)