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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment. Scale: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
Time frame: 2 Weeks Following Treatment
GERD-HRQL
Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment. Scale: 0 = No symptom 1. = Symptoms noticeable but not bothersome 2. = Symptoms noticeable and bothersome but not every day 3. = Symptoms bothersome every day 4. = Symptoms affect daily activity 5. = Symptoms are incapacitating to do daily activities
Time frame: 4 Weeks Following Treament
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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