NCT02159898

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Malignant Esophageal Strictures

Interventions

Type	Name	Description
DEVICE	EndoMAXX Endoluminal Valve Technology (EVT)
DEVICE	EndoMAXX

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2014-06-10
• Last updated: 2018-06-07
• Results posted: 2018-06-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study