Evaluation of a New Blood Pressure Measuring Device.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT00265707
Study type	Interventional
Source	Maaynei Hayesha Medical Center
Contact	Mordchai Ravid, MD FACP
Phone	972-3-5771113
Email	ravid@mhmc.co.il
Status	Recruiting
Phase	N/A
Start date	September 2005
Completion date	December 2005

View Details

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