Prognostic Indicators as Provided by the EPIC ClearView (GBMC)
This study has been completed.
Sponsor:
Epic Research & Diagnostics, Inc.
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
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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 |
|---|
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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:
Genetics Home Reference related topics:
Crohn disease
North American Indian childhood cirrhosis
celiac disease
familial atrial fibrillation
hereditary pancreatitis
ulcerative colitis
MedlinePlus related topics:
Hepatitis
Genetic and Rare Diseases Information Center resources:
Familial Atrial Fibrillation
Visceral Steatosis
Cholecystitis
U.S. FDA Resources
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.
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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.
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Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| 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:
- 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
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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.
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
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:
| 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 Hepatitis A Heart Failure Pneumonia Atrial Fibrillation Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Crohn Disease Colitis Colitis, Ulcerative Irritable Bowel Syndrome Renal Insufficiency Intestinal Diseases |
Inflammatory Bowel Diseases Pancreatitis Emphysema Bronchitis Fatty Liver Peptic Ulcer Acute Kidney Injury Diverticulitis Hepatitis, Alcoholic Cholecystitis Acalculous Cholecystitis Pyelonephritis Malabsorption Syndromes Heart Valve Diseases Celiac Disease |
ClinicalTrials.gov processed this record on September 27, 2016