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

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01076296
First received: February 24, 2010
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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
Left Ventricular Dysfunction
Right Ventricular Dysfunction
Pulmonary Hypertension
Heart Valve Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Percentage of Correct Diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 1000
Study Start Date: February 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076296

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
GE Healthcare
Oregon Health and Science University
Investigators
Principal Investigator: Sanjiv Kaul, MD Oregon Health and Science University
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01076296     History of Changes
Other Study ID Numbers: OHSU_Vscan_02 
Study First Received: February 24, 2010
Results First Received: December 16, 2015
Last Updated: February 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Valve Diseases
Ventricular Dysfunction, Right
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2016