Blood PressureNCT04379323
Clinical Trial of YuWell YE900 Electronic Sphygmomanometer
A study testing YuWell YE900 Electronic Sphygmomanometer in people with Blood Pressure, run by The Second Hospital of Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- YuWell YE900 Electronic Sphygmomanometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2020to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 3 Years and older (Child, Adult, Older Adult);
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
About this study
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
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).
- Conditions
- Blood Pressure
- Being tested
- YuWell YE900 Electronic Sphygmomanometer
- Keywords
- AAMI/ESH/ISO 81060-2: 2018 standard, blood pressure measurement, blood pressure monitor, validation study, YuWell YE900
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YuWell YE900 Electronic SphygmomanometerDiagnostic test
Also called Desk Mercury Sphygmomanometer, Blood Pressure Measurement
Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.
| Study group | Role | What they receive |
|---|---|---|
| YuWell YE900 and mercury sphygmomanometer | Experimental | Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer. Receives: Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement data
Systolic Pressure and Diastolic Pressure
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start12 May 2020
- Primary completion17 Jun 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Yuyue medical equipment & supply Co., Ltd.
- Responsible party
- Principal investigator, zhang Hui Jie, The Second Hospital of Nanjing Medical University
- Investigators
- Mingzhi Long, MD PHD, Study director, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379323
- Sponsor's protocol ID
- YUWELL-YLQX202001
- Status last verified
- Aug 2020
- First submitted
- 4 May 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34480474
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04379323
- Acronym / sponsor ID
- YUWELL-YLQX202001
- Conditions
- Blood Pressure
- Keywords
- AAMI/ESH/ISO 81060-2: 2018 standard, blood pressure measurement, blood pressure monitor, validation study, YuWell YE900
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Yuyue medical equipment & supply Co., Ltd.
- Study start
- 12 May 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YuWell YE900 and mercury sphygmomanometer | Experimental | Diagnostic Test: YuWell YE900 Electronic SphygmomanometerBlood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 3 Years and older (Child, Adult, Older Adult);
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Key exclusion criteria (6 listed)
- Disturbance of consciousness;
- Patients requiring hemodialysis;
- Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
- Pregnant and lactating women;
- Patients with cardiac arrhythmias;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YuWell YE900 Electronic SphygmomanometerAlso: Desk Mercury Sphygmomanometer, Blood Pressure MeasurementMeasurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer. | Diagnostic test | YuWell YE900 and mercury sphygmomanometer |
Primary outcome
Blood pressure measurement data
Time frame: 30 minutes
Systolic Pressure and Diastolic Pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 34480474Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingzhi Long, MD PHD study director
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YuWell YE900 Electronic Sphygmomanometer in people with Blood Pressure, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement data (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.