Brief Title
Prognostic Indicators as Provided by the EPIC ClearView
Official Title
Prognostic Indicators as Provided by the EPIC ClearView
Brief Summary
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.
Study Type
Observational
Primary Outcome
Agreement of ClearView Scan versus Active Diagnosis
Secondary Outcome
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Condition
Coronary Artery Disease
Study Arms / Comparison Groups
Controls
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
353
Start Date
September 2010
Completion Date
June 2011
Primary Completion Date
June 2011
Eligibility Criteria
Inclusion Criteria:
Five Diagnosis Group:
1. Sex: Male or Female
2. Age range: 18 to 85
3. Qualifying medical diagnoses (5 diagnosis groups)
- For potential subjects presenting with one of the five qualifying diagnoses, the
patient presents with confirmed active medical diagnoses affecting the following
systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart
failure with EF <50%, valvular heart disease, atrial fibrillation, and
hypertension
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's
disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS,
cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue);
diabetes (Type 1 and Type 2)
4. The patient or legal representative is able to understand and provide signed consent
for the procedure.
5. Every effort will be given to balance subjects by gender, age, and race. At least 60
subjects from each of the 5 diagnostic groups and the 1 control group will be
recruited.
Control Group:
1. Sex: Male or Female
2. Age range: 18 to 85
3. Freedom from qualifying medical diagnoses (control group)
- For potential subjects for the control group, the subject is free from active
medical diagnoses affecting the following systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart
failure with EF <50%, valvular heart disease, atrial fibrillation, and
hypertension
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's
disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS,
cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue);
diabetes (type 1 and type 2)
4. The patient or legal representative is able to understand and provide signed consent
for the procedure.
5. Every effort will be given to balance subjects by gender, age, and race. At least 60
subjects from each of the 5 diagnostic groups and the 1 control group will be
recruited.
Exclusion Criteria:
- Patients < 18 years in age or > 85 years in age.
- Inability or unwillingness to provide informed consent.
- Patients with pacemakers or another electrical device implanted somewhere in their
body.
- Pregnant women.
- Patients currently undergoing therapy for cancer of any kind.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clair A Francomano, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01476995
Organization ID
GBMC Triage Study
Responsible Party
Sponsor
Study Sponsor
Epic Research & Diagnostics, Inc.
Study Sponsor
Clair A Francomano, MD, Principal Investigator, Greater Baltimore Medical Center
Verification Date
November 2011