Prognostic Indicators as Provided by the EPIC ClearView (GBMC)
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|ClinicalTrials.gov Identifier: NCT01476995|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
|Condition or disease|
|Coronary Artery Disease Congestive Heart Failure Valvular Heart Disease Atrial Fibrillation Hypertension Pyelonephritis Acute Renal Failure Renal Failure Viral Hepatitis Alcoholic Hepatitis Steatohepatitis Cirrhosis Asthma COPD Bronchitis Emphysema Pneumonia Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Diverticulitis Peptic Ulcer Disease Irritable Bowel Syndrome Cholecystitis Pancreatitis Malabsorption Disorders Celiac Sprue Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||353 participants|
|Observational Model:||Case Control|
|Official Title:||Prognostic Indicators as Provided by the EPIC ClearView|
|Study Start Date :||September 2010|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Men and women ages 18-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs.
Five Diagnosis Group
Men and women ages 18-85 with at least one active medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs.
- Agreement of ClearView Scan versus Active Diagnosis [ Time Frame: At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit). ]Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the physician's diagnoses recorded within the medical record, on a per-subject basis.
- Sensitivity and Specificity of ClearView Scan versus Active Diagnosis [ Time Frame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit. ]Sensitivity and Specificity of the ClearView Scan relative to an active diagnosis, as the proportion of subjects with correctly captured findings amongst those with an active diagnosis and the proportion of subjects without a ClearView finding amongst those without an active diagnosis, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476995
|United States, Maryland|
|Greater Baltimore Medical Cente|
|Baltimore, Maryland, United States, 21204|
|Principal Investigator:||Clair A Francomano, MD||Greater Baltimore Medical Center|