Blood Pressure Monitor Clinical Test (Cuff Range: 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm)
Sponsor
Andon Health Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05978999
Collaborator
(none)
90
1
2.8
32.6
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Blood Pressure Monitor#Model#BPM1#Clinical Test
Actual Study Start Date
:
Apr 7, 2021
Actual Primary Completion Date
:
Jun 30, 2021
Actual Study Completion Date
:
Jun 30, 2021
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Subject use both BPM1 Arm Automatic Electronic BPM and mercury sphygmomanometers
|
Outcome Measures
Primary Outcome Measures
- blood pressure monitor accuracy [30 minutes]
All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | China |
Sponsors and Collaborators
- Andon Health Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Andon Health Co., Ltd
ClinicalTrials.gov Identifier:
NCT05978999
Other Study ID Numbers:
- Andon Health 12
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No