CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
EndoMAXX Endoluminal Valve Technology (EVT) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02159898
NCT02159898N/ACompleted

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

Merit Medical Systems, Inc.·interventional·Posted Jun 10, 2014·Updated Jun 7, 2018

In Brief

A clinical study evaluating EndoMAXX Endoluminal Valve Technology (EVT) and EndoMAXX for Malignant Esophageal Strictures. Completed, enrolled 60 participants across 7 sites.

Detailed 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).

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionOct 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.1 years ago

Interventions

EndoMAXX Endoluminal Valve Technology (EVT)device

EndoMAXXdevice