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Study Hypothesis:
Upper endoscopy (EGD) is employed to diagnose BE; however, the cost and invasiveness of this diagnostic tool limits its utilization in many patients (17). There is a need for an alternative, simple, and less invasive diagnostic tool for evaluating GERD patients and screening for BE. Esophageal capsule endoscopy (ECE) is a novel technique that offers non-invasive evaluation of esophageal pathology in gastroesophageal reflux disease (GERD) patients. The potential benefits of screening patients by Capsule Endoscopy (CE) are several. Detection of esophageal pathology during CE could select a subgroup of patients for upper endoscopy avoiding the risks and costs of an upper endoscopy in the majority. Other benefits include convenience, ability to perform the test on an outpatient basis in less than 30 minutes, patient acceptability, minimal loss of work time, safety, tolerability, the ability of non-physicians to screen patients, and potentially, improved compliance with screening recommendations. Recently, a new, high resolution capsule (ESO 2) with a larger field of view and better illumination than the previous CE has been introduced. A simplified ingestion protocol for CE that improves visualization of the Z-line has also been reported as well (17).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with known Barrett's Esophagus or chronic GERD |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated. | 7 days | |
| Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with known Barrett's Esophagus or chronic GERD
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| Name | Affiliation | Role |
|---|---|---|
| Glen Eisen, MD | Oregon Health and Science University | Principal Investigator |
| Prateek Sharma, MD | Department of VA Medical Affairs Medical Center of Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| University of Illinois at Chicago |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 7 days |
| Subjects' satisfaction will be assessed by a post procedure questionnaire | 7 days |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Rockford Gastroenterolgy Assoicates | Rockford | Illinois | 61107 | United States |
| Minnesota Gastroenterology | Minneapolis | Minnesota | 55446 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Department of VA Medical Affairs Medical Center of Kansas City | Kansas City | Missouri | 66160 | United States |
| New York Gastroenterology Assoicates | New York | New York | 10021 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |