Evaluation of a New Blood Pressure Measuring Device.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265707
Recruitment Status : Unknown
Verified December 2005 by Maaynei Hayesha Medical Center.
Recruitment status was:  Recruiting
First Posted : December 15, 2005
Last Update Posted : October 9, 2006
Information provided by:
Maaynei Hayesha Medical Center

Brief Summary:
  • A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
  • Up to 100 subjects with various levels of blood pressure values will be tested.

Condition or disease Intervention/treatment
Hypertension Device: Blood pressure measurement

Detailed Description:

The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

  • Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
  • Each measurement will be performed simultaneously by two examiners specially trained.
  • Informed consent will be obtained from all participants.
  • The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
Study Start Date : September 2005
Estimated Study Completion Date : December 2005

Primary Outcome Measures :
  1. The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, age 18 years or above
  • Signed written informed consent

Exclusion Criteria:

  • A history of cardiac arrythmia
  • Wrist circumference smaller than 13cm or larger than 19.5cm
  • Documented peripheral vascular disease
  • Damage or injury to the left wrist
  • Participation in any other clinical study
  • Any acute coronary of cardiovascular illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265707

Contact: Mordchai Ravid, MD FACP 972-3-5771113
Contact: Itzhak Klinger, MD 972-3-5771216

Department of Medicine, Maaynei Hayesha Hospital Recruiting
Tel Aviv, Israel, 51544
Contact: Itzhak Klinger, MD    972-3-5771216   
Principal Investigator: Mordchai Ravid, MD FACP         
Sponsors and Collaborators
Maaynei Hayesha Medical Center
Principal Investigator: Mordchai Ravid, MD FACP Maaynei Hayesha Hospital Identifier: NCT00265707     History of Changes
Other Study ID Numbers: DPTYN001CTIL
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: December 2005

Keywords provided by Maaynei Hayesha Medical Center:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases