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EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

NCT02159898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-07

Study results available
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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

DEVICE

EndoMAXX Endoluminal Valve Technology (EVT)

DEVICE

EndoMAXX

Sponsors & Collaborators

  • Geisinger Clinic

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Kulwinder DUA, MD · Medical College of WI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-10-31
Completion
2016-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02159898 on ClinicalTrials.gov