Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

• Sponsor: The Second Hospital of Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04379323
• Collaborator: Jiangsu Yuyue medical equipment & supply Co., Ltd. (Other)
• Enrollment: 92
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 47.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: May 12, 2020
• Actual Primary Completion Date: Jun 17, 2020
• Actual Study Completion Date: Jul 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YuWell YE900 and mercury sphygmomanometer Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.	Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer; Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.; Other Names: Desk Mercury Sphygmomanometer Blood Pressure Measurement

Outcome Measures

Primary Outcome Measures

1. Blood pressure measurement data [30 minutes]

   Systolic Pressure and Diastolic Pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011

Sponsors and Collaborators

• The Second Hospital of Nanjing Medical University
• Jiangsu Yuyue medical equipment & supply Co., Ltd.

Investigators

• Study Director: Mingzhi Long, MD PHD, The Second Hospital of Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: zhang Hui Jie, Director of Clinical trial center, The Second Hospital of Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04379323
• Other Study ID Numbers: YUWELL-YLQX202001
• First Posted: May 7, 2020
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by zhang Hui Jie, Director of Clinical trial center, The Second Hospital of Nanjing Medical University: AAMI/ESH/ISO 81060-2: 2018 standard; blood pressure measurement; blood pressure monitor; validation study; YuWell YE900

Study Results

No Results Posted as of Aug 19, 2020