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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014