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Evaluation of a New Blood Pressure Measuring Device.

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood pressure measurement
Sponsored by
Maaynei Hayesha Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring Hypertension, Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Maaynei Hayesha HospitalRecruiting

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2005
Last Updated
October 6, 2006
Sponsor
Maaynei Hayesha Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00265707
Brief Title
Evaluation of a New Blood Pressure Measuring Device.
Official Title
A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maaynei Hayesha Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Hypotension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Blood pressure measurement
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mordchai Ravid, MD FACP
Phone
972-3-5771113
Email
ravid@mhmc.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Itzhak Klinger, MD
Phone
972-3-5771216
Email
klinger@mhmc.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordchai Ravid, MD FACP
Organizational Affiliation
Maaynei Hayesha Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Maaynei Hayesha Hospital
City
Tel Aviv
ZIP/Postal Code
51544
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itzhak Klinger, MD
Phone
972-3-5771216
Email
klinger@mhmc.co.il
First Name & Middle Initial & Last Name & Degree
Mordchai Ravid, MD FACP

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a New Blood Pressure Measuring Device.

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