Text Size

Clinical Test for Blood Pressure Meter of CH-101

This study has been completed.
Sponsor:
Information provided by:
Citizen Systems Japan Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01029119
First received: December 7, 2009
Last updated: December 8, 2009
Last verified: December 2009
History of Changes
  Purpose

Blood pressure meter model CH-101 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
Official Title: Clinical Test of Blood Pressure Meter of CH-101

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-101 assessed 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: August 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   22 Years to 84 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 antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029119

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: NCT01029119     History of Changes
Other Study ID Numbers: Citizen - CH101
Study First Received: December 7, 2009
Last Updated: December 8, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Citizen Systems Japan Co., Ltd.:
blood pressure

ClinicalTrials.gov processed this record on June 13, 2013