Study Hypothesis: * PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis. * PillCam™ ESO will demonstrate all safety parameters as compared to EGD * PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
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).
Study Type
OBSERVATIONAL
Enrollment
101
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Rockford Gastroenterolgy Assoicates
Rockford, Illinois, United States
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.
Time frame: 7 days
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.
Time frame: 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.
Time frame: 7 days
Subjects' satisfaction will be assessed by a post procedure questionnaire
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Minnesota Gastroenterology
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Department of VA Medical Affairs Medical Center of Kansas City
Kansas City, Missouri, United States
New York Gastroenterology Assoicates
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Virginia Mason Medical Center
Seattle, Washington, United States