An observational study in Coronary Artery Disease, Congestive Heart Failure and Valvular Heart Disease, sponsored by Epic Research & Diagnostics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-22.
Sponsored by Epic Research & Diagnostics, Inc. · Observational
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 353 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Epic Research & Diagnostics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant, and cannot be undergoing cancer therapy of any kind.
Five Diagnosis Group:
Qualifying medical diagnoses (5 diagnosis groups)
Control Group:
Freedom from qualifying medical diagnoses (control group)
Exclusion Criteria:
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.
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
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.
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).
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
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.
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.
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Epic Research & Diagnostics, Inc.