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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
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
GE Healthcare

Study Description
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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.

Condition or disease
Left Ventricular Dysfunction Right Ventricular Dysfunction Pulmonary Hypertension Heart Valve Diseases

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 Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-patient and outpatient population of OHSU Division of Cardiovascular Medicine
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
GE Healthcare
Oregon Health and Science University
Investigators
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Principal Investigator: Sanjiv Kaul, MD Oregon Health and Science University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01076296    
Other Study ID Numbers: OHSU_Vscan_02
First Posted: February 26, 2010    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Valve Diseases
Ventricular Dysfunction, Right
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases