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

NCT01076296 | Completed Results

• 1 other identifier: OHSU_Vscan_02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Dysfunction; Right Ventricular Dysfunction; Pulmonary Hypertension; Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-patient and outpatient population of OHSU Division of Cardiovascular Medicine

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• less than 18 years of age.
• unwilling to provide informed Consent

Sponsors & Collaborators

• GE Healthcare: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Results Point of Contact

• Title: Anita Johnson
• Organization: GE Healthcare

Anita.Johnson@ge.com

262-548-2825

Study Officials

• Sanjiv Kaul, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02

Locations

US (1)