Prognostic Indicators as Provided by the EPIC ClearView (GBMC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01476995
First received: October 3, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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
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 Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prognostic Indicators as Provided by the EPIC ClearView

Resource links provided by NLM:


Further study details as provided by Epic Research & Diagnostics, Inc.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 353
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476995

Locations
United States, Maryland
Greater Baltimore Medical Cente
Baltimore, Maryland, United States, 21204
Sponsors and Collaborators
Epic Research & Diagnostics, Inc.
Investigators
Principal Investigator: Clair A Francomano, MD Greater Baltimore Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01476995     History of Changes
Other Study ID Numbers: GBMC Triage Study
Study First Received: October 3, 2011
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Epic Research & Diagnostics, Inc.:
Cardiovascular system
gastrointestinal system
kidneys
liver
lungs

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Asthma
Atrial Fibrillation
Bronchitis
Celiac Disease
Cholecystitis
Acalculous Cholecystitis
Colitis
Colitis, Ulcerative
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Crohn Disease
Diverticulitis
Emphysema
Pulmonary Emphysema
Heart Diseases
Heart Failure
Heart Valve Diseases
Hepatitis
Hepatitis A
Hypertension
Inflammatory Bowel Diseases
Intestinal Diseases
Irritable Bowel Syndrome
Acute Kidney Injury
Liver Cirrhosis
Fibrosis
Malabsorption Syndromes
Pancreatitis

ClinicalTrials.gov processed this record on July 26, 2014