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

NCT ID: NCT05482035

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-16

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer

Group Type EXPERIMENTAL

wrist blood pressure monitor

Intervention Type DEVICE

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

Interventions

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wrist blood pressure monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huawei Device Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shenzhen No.2 People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CTP-YBN2021075026A2

Identifier Type: -

Identifier Source: org_study_id

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