Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

NCT ID: NCT04379323

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2020-07-10

Brief Summary

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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).

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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YuWell YE900 and mercury sphygmomanometer

Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.

Group Type EXPERIMENTAL

YuWell YE900 Electronic Sphygmomanometer

Intervention Type DIAGNOSTIC_TEST

Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.

Interventions

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YuWell YE900 Electronic Sphygmomanometer

Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Desk Mercury Sphygmomanometer Blood Pressure Measurement

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Yuyue medical equipment & supply Co., Ltd.

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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zhang Hui Jie

Director of Clinical trial center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingzhi Long, MD PHD

Role: STUDY_DIRECTOR

The Second Hospital of Nanjing Medical University

Locations

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The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34480474 (View on PubMed)

Other Identifiers

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YUWELL-YLQX202001

Identifier Type: -

Identifier Source: org_study_id

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