A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
Left Ventricular Dysfunction
Right Ventricular Dysfunction
Heart Valve Diseases
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System|
- Percentage of Correct Diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076296
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Sanjiv Kaul, MD||Oregon Health and Science University|