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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by GE Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01076296
First received: February 24, 2010
Last updated: February 25, 2010
Last verified: February 2010
  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
Ultrasonography

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

Further study details as provided by GE Healthcare:

Estimated Enrollment: 370
Study Start Date: February 2010
Estimated Primary Completion Date: December 2010 (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 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
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 Recruiting
Portland, Oregon, United States, 97239
Contact: Sanjiv Kaul, MD    503-494-8750      
Principal Investigator: Sanjiv Kaul, MD         
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Sanjiv Kaul, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Sanjiv Kaul, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01076296     History of Changes
Other Study ID Numbers: OHSU_Vscan_02
Study First Received: February 24, 2010
Last Updated: February 25, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014