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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 Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Left Ventricular Dysfunction
Right Ventricular Dysfunction
Pulmonary Hypertension
Heart Valve Diseases

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Abnormal Left Ventricle Function Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
Normal Left Ventricle Function Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
Abnormal Right Ventricle Function Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
Normal Right Ventricle Function Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
Pulmonary Hypertension Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
No Pulmonary Hypertension Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
Heart Valve Disease Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
No Heart Valve Disease Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.

Participant Flow:   Overall Study
    Abnormal Left Ventricle Function   Normal Left Ventricle Function   Abnormal Right Ventricle Function   Normal Right Ventricle Function   Pulmonary Hypertension   No Pulmonary Hypertension   Heart Valve Disease   No Heart Valve Disease
STARTED   54   196   51   199   59   191   51   199 
COMPLETED   54   196   51   199   59   191   51   199 
NOT COMPLETED   0   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total for All Groups Assessed Subjects assessed for LV function using both VScan and a clinical examination.

Baseline Measures
   Total for All Groups Assessed 
Overall Participants Analyzed 
[Units: Participants]
 1000 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (15.4) 
Gender 
[Units: Participants]
 
Female   656 
Male   344 


  Outcome Measures

1.  Primary:   Percentage of Correct Diagnosis   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anita Johnson
Organization: GE Healthcare
phone: 262-548-2825
e-mail: Anita.Johnson@ge.com



Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01076296     History of Changes
Other Study ID Numbers: OHSU_Vscan_02
First Submitted: February 24, 2010
First Posted: February 26, 2010
Results First Submitted: December 16, 2015
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016