Prognostic Indicators as Provided by the EPIC ClearView (GBMC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01476995 |
Recruitment Status :
Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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.
|
- 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.
- 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.

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, Learn About Clinical Studies.
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 |
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.

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
United States, Maryland | |
Greater Baltimore Medical Cente | |
Baltimore, Maryland, United States, 21204 |
Principal Investigator: | Clair A Francomano, MD | Greater Baltimore Medical Center |
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 |
Cardiovascular system gastrointestinal system kidneys liver lungs |
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 |