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

NCT ID: NCT01076296

Last Updated: 2016-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Left Ventricular Dysfunction Right Ventricular Dysfunction Pulmonary Hypertension Heart Valve Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjiv Kaul, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU_Vscan_02

Identifier Type: -

Identifier Source: org_study_id

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