This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.
The study requires 2 visits to OHSU. At the first visit a cardiac physical exam will be done by a cardiologist. At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.
Study Type
OBSERVATIONAL
Enrollment
1,000
Oregon Health & Science University
Portland, Oregon, United States
Percentage of Correct Diagnosis
A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.
Time frame: 2 years
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