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

Validation of the YuWell YE660D Oscillometric Upper-arm Blood Pressure Monitor for Clinic and Home in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04931264

Enrollment

Registered

2021-06-18

Start date

2021-09-01

Completion date

2022-03-08

Last updated

2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

blood pressure monitor, blood pressure measurement, validation study, AAMI/ESH/ISO Universal Standard, ISO 81060-2:2018, YuWell YE660D

Brief summary

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).

Interventions

DIAGNOSTIC_TESTYuWell YE660D Electronic Sphygmomanometer

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure measurement data	30 minutes	Systolic Pressure and Diastolic Pressure

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026