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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076296
• Other study ID #: OHSU_Vscan_02
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 8, 2016
• Start date: February 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2016
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No