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Brief Title: EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
Official Title: Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction
Study ID: NCT02159898
Brief Summary: This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Colorado Denver, Aurora, Colorado, United States
University of Florida, Gainesville, Florida, United States
Indiana University, Indianapolis, Indiana, United States
Mayo Clinic, Rochester, Minnesota, United States
Weill Cornell Medical College, New York, New York, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Kulwinder DUA, MD
Affiliation: Medical College of WI
Role: PRINCIPAL_INVESTIGATOR