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

Blood Pressure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931264
• Other study ID #: YUWELL-YLQX202101
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: March 2022
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 8, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Diagnostic Test:
• YuWell YE660D Electronic Sphygmomanometer
Measurement blood pressure by YuWell YE660D 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