A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01076296|
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
|Condition or disease|
|Left Ventricular Dysfunction Right Ventricular Dysfunction Pulmonary Hypertension Heart Valve Diseases|
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|
|Actual Enrollment :||1000 participants|
|Official Title:||A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
- Percentage of Correct Diagnosis [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076296
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Sanjiv Kaul, MD||Oregon Health and Science University|