NCT00265707UnknownNot Applicable
A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
Maaynei Hayesha Medical Center2 sites in 1 country120 target enrollmentStarted: September 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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