NCT04931264

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

June 12, 2021

Last Update Submit

March 9, 2022

Conditions

Blood Pressure

Keywords

blood pressure monitorblood pressure measurementvalidation studyAAMI/ESH/ISO Universal StandardISO 81060-2:2018YuWell YE660D

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measurement data

    Systolic Pressure and Diastolic Pressure

    30 minutes

Study Arms (1)

YuWell YE660D and mercury sphygmomanometer

EXPERIMENTAL

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

Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer

Interventions

YuWell YE660D Electronic SphygmomanometerDIAGNOSTIC_TEST

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

YuWell YE660D and mercury sphygmomanometer

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Study Officials

  • Mingzhi Long, MD，PHD

    The Second Hospital of Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Trial Center

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 18, 2021

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 8, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)