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

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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
Enrollment 1000
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality. Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality. Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality. Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality. Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension. Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension. Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD. Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
Period Title: Overall Study
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
Arm/Group Title Total for All Groups Assessed
Hide Arm/Group Description Subjects assessed for LV function using both VScan and a clinical examination.
Overall Number of Baseline Participants 1000
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1000 participants
60.9  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1000 participants
Female
656
  65.6%
Male
344
  34.4%
1.Primary Outcome
Title Percentage of Correct Diagnosis
Hide Description 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.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
Overall Number of Participants Analyzed 54 196 51 199 59 191 51 199
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of correct diagnosis
61
(45 to 77)
31
(23 to 39)
47
(26 to 67)
6
(1 to 12)
10
(8 to 29)
3
(3 to 9)
39
(19 to 59)
4
(2 to 9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality. Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality. Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality. Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality. Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension. Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension. Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD. Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/196 (0.00%)   0/51 (0.00%)   0/199 (0.00%)   0/59 (0.00%)   0/191 (0.00%)   0/51 (0.00%)   0/199 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/196 (0.00%)   0/51 (0.00%)   0/199 (0.00%)   0/59 (0.00%)   0/191 (0.00%)   0/51 (0.00%)   0/199 (0.00%) 
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.
Results Point of Contact
Name/Title: Anita Johnson
Organization: GE Healthcare
Phone: 262-548-2825
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