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OpenTrials
Completed

NCT Number: NCT01076296

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

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.

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Key information

Conditions

Left Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Hypertension Respiratory Tract Diseases Right Ventricular Dysfunction Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Oregon Health and Science University

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2010
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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