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Evaluation of a New Blood Pressure Measuring Device.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Maaynei Hayesha Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265707
First Posted: December 15, 2005
Last Update Posted: October 9, 2006
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.
Information provided by:
Maaynei Hayesha Medical Center
  Purpose
  • 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 Intervention
Hypertension Device: Blood pressure measurement

Study Type: Interventional
Study Design: 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.

Further study details as provided by Maaynei Hayesha Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00265707


Contacts
Contact: Mordchai Ravid, MD FACP 972-3-5771113 ravid@mhmc.co.il
Contact: Itzhak Klinger, MD 972-3-5771216 klinger@mhmc.co.il

Locations
Israel
Department of Medicine, Maaynei Hayesha Hospital Recruiting
Tel Aviv, Israel, 51544
Contact: Itzhak Klinger, MD    972-3-5771216    klinger@mhmc.co.il   
Principal Investigator: Mordchai Ravid, MD FACP         
Sponsors and Collaborators
Maaynei Hayesha Medical Center
Investigators
Principal Investigator: Mordchai Ravid, MD FACP Maaynei Hayesha Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00265707     History of Changes
Other Study ID Numbers: DPTYN001CTIL
First Submitted: December 14, 2005
First Posted: December 15, 2005
Last Update Posted: October 9, 2006
Last Verified: December 2005

Keywords provided by Maaynei Hayesha Medical Center:
Hypertension
Hypotension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases