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Prognostic Indicators as Provided by the EPIC ClearView (GBMC)

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ClinicalTrials.gov Identifier: NCT01476995
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Epic Research & Diagnostics, Inc.

Study Description
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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
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
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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 : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476995


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

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Responsible Party: Epic Research & Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01476995    
Other Study ID Numbers: GBMC Triage Study
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011
Keywords provided by Epic Research & Diagnostics, Inc.:
Cardiovascular system
gastrointestinal system
kidneys
liver
lungs
Additional relevant MeSH terms:
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Diverticulitis
Hepatitis A
Hepatitis
Crohn Disease
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Pancreatitis
Fatty Liver
Peptic Ulcer
Cholecystitis
Hepatitis, Alcoholic
Celiac Disease
Bronchitis
Renal Insufficiency
Acute Kidney Injury
 Pyelonephritis
Heart Failure
Atrial Fibrillation
Coronary Artery Disease
Heart Diseases
Heart Valve Diseases
Emphysema
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections