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Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-22cm)

Sponsor
Andon Health Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05978453
Collaborator
(none)
90
Enrollment
1
Location
2.8
Actual Duration (Months)
32.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to verify the accurancy of the blood pressure monitor device.

Cuff size of arm circumference: 13.5cm- 22cm.

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#BP7# Clincial 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 BP7 Wrist Automatic Electronic BPM and mercury sphygmomanometers

    Outcome Measures

    Primary Outcome Measures

    1. blood pressure monitor accurancy [30 minutes]

      All the test results of the electronic blood pressure monitor 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 Tianjin China 300190

    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:
    NCT05978453
    Other Study ID Numbers:
    • Andon Health 11
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Mar 1, 2022
    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
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Aug 7, 2023