Clinical Test Report for Blood Pressure Meter of CH-658

Sponsor
Citizen Systems Japan Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01182454
Collaborator
(none)
96
2
1
48
47.1

Study Details

Study Description

Brief Summary

Blood pressure meter model CH-658 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    96 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Feb 1, 2010
    Actual Study Completion Date :
    Feb 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Measure accuracy of blood pressure meter CH-658 [30 minutes]

      Measure the accuracy of blood pressure meter model CH-658 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 62 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 96 subjects with a wide range of blood pressure were selected.
    Exclusion Criteria:
    • Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sone Clinic Tokyo Japan
    2 Sone Clinic Toyko Japan

    Sponsors and Collaborators

    • Citizen Systems Japan Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01182454
    Other Study ID Numbers:
    • Citizen-658
    First Posted:
    Aug 16, 2010
    Last Update Posted:
    Aug 16, 2010
    Last Verified:
    Aug 1, 2010
    Keywords provided by , ,

    Study Results

    No Results Posted as of Aug 16, 2010