Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379323
• Other study ID #: YUWELL-YLQX202001
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: July 10, 2020

Study information

• Verified date: August 2020
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 10, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Diagnostic Test:
• YuWell YE900 Electronic Sphygmomanometer
Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	Jiangsu Yuyue medical equipment & supply Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure measurement data	Systolic Pressure and Diastolic Pressure	30 minutes