Prognostic Indicators as Provided by the EPIC ClearView

Completed

• Conditions: Coronary Artery Disease; Congestive Heart Failure; Valvular Heart Disease; Atrial Fibrillation; Hypertension; Pyelonephritis; Acute Renal Failure; Renal Failure; Viral Hepatitis; Alcoholic Hepatitis

• Registration Number: NCT01476995
• Lead Sponsor: Epic Research & Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-10-03
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-18
• Last Update Submitted: 2011-11-18
• Study First Posted: 2011-11-22
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Greater Baltimore Medical Cente; 🇺🇸 Baltimore, Maryland, United States