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

Completed

• Conditions: Pulmonary Hypertension; Right Ventricular Dysfunction; Left Ventricular Dysfunction; Heart Valve Diseases

• Registration Number: NCT01076296
• Lead Sponsor: GE Healthcare

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2015-12-16
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-08
• Last Update Submitted: 2016-02-08
• Results First Posted: 2016-03-07
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18 years or older
• provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study
• New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care

Exclusion Criteria

• Pregnant
• less than 18 years of age.
• unwilling to provide informed Consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Correct Diagnosis	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States