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

NCT05482035 | Completed

• 1 other identifier: CTP-YBN2021075026A2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer

EXPERIMENTAL

Device: wrist blood pressure monitor

Interventions

wrist blood pressure monitor DEVICE

Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
• Subjects with prior arterial obstructive disease or arteritis.
• Subjects who had previously undergone mastectomy.
• Subjects with wound or wrist inflammation were measured.
• Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
• Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
• Subjects who have participated in other clinical trials within 30 days that may affect this trial.
• Subjects who the investigator consider inappropriate to attend the trial.

Sponsors & Collaborators

• Huawei Device Co., Ltd: lead

Study Sites (1)

Shenzhen No.2 People's Hospital

Shenzhen, Guangdong, 518035, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: February 16, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

CN (1)