NCT00885469

PillCam® ESO 2 in Esophageal Pathologies

Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Barrett's Esophagus
• Gastroesophageal Reflux Disease

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-04-22
• Last updated: 2019-07-31

Locations

10 sites across 1 country: United States