Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04379323

Enrollment

Registered

2020-05-07

Start date

2020-05-12

Completion date

2020-07-10

Last updated

2020-08-19

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

Conditions

Blood Pressure

Keywords

AAMI/ESH/ISO 81060-2: 2018 standard, blood pressure measurement, blood pressure monitor, validation study, YuWell YE900

Brief summary

The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children 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 YE900 Electronic Sphygmomanometer

Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. 3 Years and older (Child, Adult, Older Adult); 2. Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

1. Disturbance of consciousness; 2. Patients requiring hemodialysis; 3. Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases; 4. Pregnant and lactating women; 5. Patients with cardiac arrhythmias; 6. 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