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Clinical Test Report for Blood Pressure Meter CH-609

This study has been completed.
Sponsor:
Information provided by:
Citizen Systems Japan Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01044849
First received: January 7, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

Blood pressure meter model CH-609 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Condition
Blood Pressure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:

MedlinePlus related topics: Mercury
U.S. FDA Resources

Further study details as provided by Citizen Systems Japan Co., Ltd.:

Primary Outcome Measures:
  • Measure the accuracy of blood pressure meter model CH-609 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   22 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community Sample

Criteria

Inclusion Criteria:

  • 85 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044849

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Citizen Systems Japan Co., Ltd.
  More Information

No publications provided

Responsible Party: Makoto Okamoto, Citizen Systems Japan Co., Ltd.
ClinicalTrials.gov Identifier: NCT01044849     History of Changes
Other Study ID Numbers: CH-609
Study First Received: January 7, 2010
Last Updated: January 7, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Citizen Systems Japan Co., Ltd.:
Blood Pressure

ClinicalTrials.gov processed this record on May 19, 2013