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Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-19.5cm）

Sponsor
Andon Health Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT06117787
Collaborator
(none)
90
Enrollment
1
Location
13.8
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to verify the accuracy of the blood pressure cuffs with blood pressure monitor device.

Cuff circumference is 13.5cm-19.5cm.

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#KD-7920#Clinical Test
    Actual Study Start Date :
    Apr 2, 2022
    Actual Primary Completion Date :
    May 28, 2023
    Actual Study Completion Date :
    May 28, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Subject use both KD-7920 Wrist Automatic Electronic BPM and mercury sphygmomanometers

    Outcome Measures

    Primary Outcome Measures

    1. blood pressure monitor accuracy [30 minutes]

      All the test results of the electronic blood pressure monitor with the cuff 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:
    NCT06117787
    Other Study ID Numbers:
    • Andon Health 13
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 7, 2023