Evaluation of a New Blood Pressure Measuring Device.
|ClinicalTrials.gov Identifier: NCT00265707|
Recruitment Status : Unknown
Verified December 2005 by Maaynei Hayesha Medical Center.
Recruitment status was: Recruiting
First Posted : December 15, 2005
Last Update Posted : October 9, 2006
- 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 or disease||Intervention/treatment|
|Hypertension||Device: Blood pressure measurement|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||December 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265707
|Contact: Mordchai Ravid, MD FACPemail@example.com|
|Contact: Itzhak Klinger, MDfirstname.lastname@example.org|
|Department of Medicine, Maaynei Hayesha Hospital||Recruiting|
|Tel Aviv, Israel, 51544|
|Contact: Itzhak Klinger, MD 972-3-5771216 email@example.com|
|Principal Investigator: Mordchai Ravid, MD FACP|
|Principal Investigator:||Mordchai Ravid, MD FACP||Maaynei Hayesha Hospital|