Clinical trial NCT01476995: Prognostic Indicators as Provided by the EPIC ClearView
Official title: Prognostic Indicators as Provided by the EPIC ClearView
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Cardiovascular system
gastrointestinal system
kidneys
liver
lungs
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant, and cannot be undergoing cancer therapy of any kind.

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.


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.

Primary outcomes:
measure: Agreement of ClearView Scan versus Active Diagnosis
timeFrame: 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).
Secondary outcomes:
measure: Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
timeFrame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Greater Baltimore Medical Cente
state: Maryland
Study officials:
affiliation: Greater Baltimore Medical Center
name: Clair A Francomano, MD
role: PRINCIPAL_INVESTIGATOR
References: