Prognostic Indicators as Provided by the EPIC ClearView

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.

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

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