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NCT05978999 Clinical Trial

Blood Pressure Monitor Clinical Test (Cuff Range: 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm)

Blood Pressure Clinical Trial

Official title:
Blood Pressure Monitor#Model#BPM1#Clinical Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05978999
Other study ID # Andon Health 12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 7, 2021
Est. completion date June 30, 2021

Study information
Verified date March 2022
Source Andon Health Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device. Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Normal blood pressure and hypertensive patients over 12 years old Exclusion Criteria: - Patients with serious arrhythmias or a high frequency of arrhythmias - Pregnant woman - Other investigators believe that it is not suitable to participate in this clinical trial

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Andon Health Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary blood pressure monitor accuracy All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control 30 minutes
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