Status:
WITHDRAWN
Accuracy of Non-Invasive Blood Pressure Measurement in Adults
Lead Sponsor:
Sotera Wireless, Inc.
Conditions:
Hypertension
Hypotension
Eligibility:
All Genders
12+ years
Brief Summary
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) ...
Detailed Description
This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each...
Eligibility Criteria
Inclusion
- Subject is greater than 12 years of age at the time of screening.
- Subject's upper arm circumference is between 20cm and 55cm.
- Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is willing and able to participate for up to 60 minutes.
Exclusion
- Subject is participating in another clinical study that may interfere with the results of this study.
- Subject is unable to have a blood pressure measurement taken from either arm for any reason.
- Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01183741
Start Date
September 1 2010
End Date
October 1 2010
Last Update
June 22 2011
Active Locations (1)
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1
Scripps Clinic Rancho Bernardo
San Diego, California, United States, 92128