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NCT00265707 Clinical Trial

Evaluation of a New Blood Pressure Measuring Device.

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00265707
Other study ID # DPTYN001CTIL
Secondary ID
Status Recruiting
Phase N/A
First received December 14, 2005
Last updated October 6, 2006
Start date September 2005
Est. completion date December 2005

Study information
Verified date December 2005
Source Maaynei Hayesha Medical Center
Contact Mordchai Ravid, MD FACP
Phone 972-3-5771113
Email ravid@mhmc.co.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Blood pressure measurement

Locations
Country Name City State
Israel Department of Medicine, Maaynei Hayesha Hospital Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Maaynei Hayesha Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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