EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

May 4, 2018 updated by: Merit Medical Systems, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is 18 years of age or older
  2. Patient (or legal representative) is able to understand and provide signed informed consent
  3. Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.

Exclusion Criteria:

  1. Patient is unwilling or unable to comply with the follow-up schedule
  2. Patient is contraindicated for endoscopic procedure for any reason
  3. Patient presents with esophagorespiratory fistula
  4. Patient has previously undergone esophageal stenting or esophagectomy
  5. Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
  6. Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
  7. Removal of stent is scheduled to occur within six months
  8. Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
  9. Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EndoMAXX Endoluminal Valve Technology (EVT)
EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
Device: EndoMAXX Endoluminal Valve Technology (EVT)
Other Names:
  • EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
Active Comparator: EndoMAXX
EndoMAXX Fully Covered Esophageal Stent
Device: EndoMAXX
Other Names:
  • EndoMAXX Fully Covered Esophageal Stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
Time Frame: 2 Weeks Following 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
2 Weeks Following Treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

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
4 Weeks Following Treament

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merit Medical Systems, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
Mayo Clinic
University of Florida
Medical College of Wisconsin
Weill Medical College of Cornell University
Indiana University
Geisinger Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kulwinder DUA, MD, Medical College of WI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESO-P3-12-02

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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