Clinical Trial: EndoMAXX EVT Compared to EndoMAXX

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX EVT Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Re

Brief Summary: This is a prospective, single blinded, randomized study of EndoMAXX 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 EVT Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).

Detailed Summary:
Sponsor: Merit Medical Systems, Inc.

Current Primary Outcome: Mellow and Pinkas Dysphagia Score [ Time Frame: 2 Weeks Following Treatment ]

The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • GERD-HRQL [ Time Frame: 4 Weeks Following Treament ]
    Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment.
  • Regurgitation Questionnaire [ Time Frame: 4 Weeks Following Treatment ]
    Assess symptoms of regurgitation using a regurgitation questionnaire at 4 weeks following treatment.
  • Safety [ Time Frame: 6 Months ]
    Assess the incidence of stent migration resulting in non-performance of the stent, food impaction, and esophageal perforation.


Original Secondary Outcome: Same as current

Information By: Merit Medical Systems, Inc.

Dates:
Date Received: June 6, 2014
Date Started: January 2015
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017