Prognostic Indicators as Provided by the EPIC ClearView (GBMC)
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.
Coronary Artery Disease
Congestive Heart Failure
Valvular Heart Disease
Acute Renal Failure
Inflammatory Bowel Disease
Peptic Ulcer Disease
Irritable Bowel Syndrome
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Prognostic Indicators as Provided by the EPIC ClearView|
- 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). ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476995
|United States, Maryland|
|Greater Baltimore Medical Cente|
|Baltimore, Maryland, United States, 21204|
|Principal Investigator:||Clair A Francomano, MD||Greater Baltimore Medical Center|