Prognostic Indicators as Provided by the EPIC ClearView

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.

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Key information

Conditions

Coronary Artery Disease Acute Kidney Injury Acute Renal Failure Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Hepatitis Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Asthma Atrial Fibrillation Biliary Tract Diseases Bronchial Diseases Bronchitis COPD Cardiovascular Diseases Celiac Disease Celiac Sprue Chemically-Induced Disorders Cholecystitis Chronic Disease Cirrhosis Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Congestive Heart Failure Coronary Disease Crohn Disease Crohn's Disease Diabetes Diabetes Mellitus Digestive System Diseases Disease Attributes Diverticular Diseases Diverticulitis Duodenal Diseases Emphysema Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gallbladder Diseases Gastroenteritis Gastrointestinal Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Heart Valve Diseases Hepatitis Hepatitis, Alcoholic Hypersensitivity Hypersensitivity, Immediate Hypertension Immune System Diseases Infections Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Kidney Diseases Liver Diseases Liver Diseases, Alcoholic Lung Diseases Lung Diseases, Obstructive Malabsorption Disorders Malabsorption Syndromes Male Urogenital Diseases Metabolic Diseases Myocardial Ischemia Nephritis Nephritis, Interstitial Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Peptic Ulcer Disease Pneumonia Pulmonary Disease, Chronic Obstructive Pyelitis Pyelonephritis Renal Failure Renal Insufficiency Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Steatohepatitis Stomach Diseases Substance-Related Disorders Ulcerative Colitis Urogenital Diseases Urologic Diseases Valvular Heart Disease Vascular Diseases Viral Hepatitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Greater Baltimore Medical Cente

Baltimore, Maryland, 21204, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Five Diagnosis Group:

Sex: Male or Female
Age range: 18 to 85
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)
The patient or legal representative is able to understand and provide signed consent for the procedure.
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:

Sex: Male or Female
Age range: 18 to 85
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)
The patient or legal representative is able to understand and provide signed consent for the procedure.
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.

Treatment and study plan

Primary outcomes

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).

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.

Secondary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

Epic Research & Diagnostics, Inc.

Industry

Registry information

Acronym: GBMC

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Nov 22, 2011
Registry last updated: Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed