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
1 other identifier
interventional
92
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedAugust 19, 2020
August 1, 2020
1 month
May 4, 2020
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure measurement data
Systolic Pressure and Diastolic Pressure
30 minutes
Study Arms (1)
YuWell YE900 and mercury sphygmomanometer
EXPERIMENTALBlood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.
Interventions
Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.
Eligibility Criteria
You may qualify if:
- Years and older (Child, Adult, Older Adult);
- 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
Related Publications (1)
Zhang HJ, Zhang J, Wang SL, Zhang J, Teng LN, Zhang SJ, Zhou DJ, Long MZ. Validation of the YuWell YE900 oscillometric blood pressure monitor for professional office use in adults and children according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). Blood Press Monit. 2021 Oct 1;26(5):396-399. doi: 10.1097/MBP.0000000000000541.
PMID: 34480474DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mingzhi Long, MD PHD
The Second Hospital of Nanjing Medical University
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
May 4, 2020
First Posted
May 7, 2020
Study Start
May 12, 2020
Primary Completion
June 17, 2020
Study Completion
July 10, 2020
Last Updated
August 19, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share