Clinical Trial of Wrist Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2019/A1:2020 Standard

Clinical Trial on the Effectiveness of Blood Pressure Function of Wrist Blood Pressure Monitor

The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: wrist blood pressure monitor

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Shenzhen No.2 people's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form.
2. Subjects must be willing and able to follow the investigation procedures.
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.

Exclusion Criteria:

1. Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period.
2. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
3. Subjects with prior arterial obstructive disease or arteritis.
4. Subjects who had previously undergone mastectomy.
5. Subjects with wound or wrist inflammation were measured.
6. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
7. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial.
9. Subjects who the investigator consider inappropriate to attend the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer	Device: wrist blood pressure monitor; Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean difference of systolic blood pressure	mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
mean difference of diastolic blood pressure	mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
standard deviation of the difference of systolic blood pressure	standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
standard deviation of the difference of diastolic blood pressure	standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes

Collaborators and Investigators

• Sponsor: Huawei Device Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CTP-YBN2021075026A2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No