Evaluation of a New Blood Pressure Measuring Device.

October 6, 2006 updated by: Maaynei Hayesha Medical Center

A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 51544
        • Recruiting
        • Department of Medicine, Maaynei Hayesha Hospital
        • Contact:
        • Principal Investigator:
          • Mordchai Ravid, MD FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maaynei Hayesha Medical Center

Investigators

  • Principal Investigator: Mordchai Ravid, MD FACP, Maaynei Hayesha Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 9, 2006

Last Update Submitted That Met QC Criteria

October 6, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPTYN001CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Blood pressure measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe