Prognostic Indicators as Provided by the EPIC ClearView (GBMC)

Epic Research & Diagnostics

Status: Completed

Conditions: Coronary Artery Disease; Emphysema; Pyelonephritis; Acute Renal Failure; Cholecystitis; Irritable Bowel Syndrome; Steatohepatitis; Malabsorption Disorders; Diabetes; Inflammatory Bowel Disease; Pneumonia; COPD; Valvular Heart Disease; Cirrhosis; Celiac Sprue; Pancreatitis; Alcoholic Hepatitis; Crohn's Disease; Viral Hepatitis; Congestive Heart Failure; Hypertension; Asthma; Atrial Fibrillation; Peptic Ulcer Disease; Renal Failure; Bronchitis; Ulcerative Colitis; Diverticulitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01476995

GBMC Triage Study

Details and patient eligibility

About

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.

Enrollment: 353 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

353 participants in 2 patient 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.

Five Diagnosis Group

Description:

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.