GBMC: Prognostic Indicators as Provided by the EPIC ClearView

Sponsor

Epic Research & Diagnostics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01476995

Collaborator

(none)

353

Enrollment

Location

Duration (Months)

39.4

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Observational

Actual Enrollment :

353 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Prognostic Indicators as Provided by the EPIC ClearView

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Controls 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 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.

Outcome Measures

Primary Outcome Measures

Agreement of ClearView Scan versus Active Diagnosis [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 Outcome Measures

Sensitivity and Specificity of ClearView Scan versus Active Diagnosis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.