NCT00265707

Evaluation of a New Blood Pressure Measuring Device.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Maaynei Hayesha Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Blood pressure measurement

Timeline

• Start date: 2005-09-01
• Completion: 2005-12-01
• First posted: 2005-12-15
• Last updated: 2006-10-09

Locations

1 site across 1 country: Israel