NCT01076296

A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Left Ventricular Dysfunction
• Right Ventricular Dysfunction
• Pulmonary Hypertension
• Heart Valve Diseases

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-02-26
• Last updated: 2016-03-07
• Results posted: 2016-03-07

Locations

1 site across 1 country: United States