Clinical Trial of YuWell YE660D Blood Pressure Monitor in General Population According to the ISO 81060-2:2018

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-03-08

Brief Summary

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The purpose of this study is to evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

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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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YuWell YE660D and mercury sphygmomanometer

Blood Pressure Measurement with the YuWell YE660D Electronic Sphygmomanometer (YuWell YE660D) and with Desk Mercury Sphygmomanometer.

Group Type EXPERIMENTAL

YuWell YE660D Electronic Sphygmomanometer

Intervention Type DIAGNOSTIC_TEST

Measurement blood pressure by YuWell YE660D Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer

Interventions

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YuWell YE660D Electronic Sphygmomanometer

Measurement blood pressure by YuWell YE660D Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 12 Years and older;
* Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria

* Disturbance of consciousness;
* Patients requiring hemodialysis;
* Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
* Pregnant and lactating women;
* Patients with cardiac arrhythmias;
* Other conditions that the investigator considers ineligible for clinical trial.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes