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EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Primary Purpose

Malignant Esophageal Strictures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EndoMAXX Endoluminal Valve Technology (EVT)
EndoMAXX
Sponsored by
Merit Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Esophageal Strictures focused on measuring Esophageal Cancer, Dysphagia, Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Denver
  • University of Florida
  • Indiana University
  • Mayo Clinic
  • Weill Cornell Medical College
  • Geisinger Medical Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EndoMAXX Endoluminal Valve Technology (EVT)

EndoMAXX

Arm Description

EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve

EndoMAXX Fully Covered Esophageal Stent

Outcomes

Primary Outcome Measures

Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the 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. = able to swallow some solid foods = able to swallow only semi solid foods = able to swallow liquids only = unable to swallow anything / total dysphagia

Secondary Outcome Measures

GERD-HRQL
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 = Symptoms noticeable but not bothersome = Symptoms noticeable and bothersome but not every day = Symptoms bothersome every day = Symptoms affect daily activity = Symptoms are incapacitating to do daily activities

Full Information

First Posted
June 6, 2014
Last Updated
May 4, 2018
Sponsor
Merit Medical Systems, Inc.
Collaborators
Geisinger Clinic, Medical College of Wisconsin, Indiana University, University of Colorado, Denver, Mayo Clinic, Weill Medical College of Cornell University, University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02159898
Brief Title
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit Medical Systems, Inc.
Collaborators
Geisinger Clinic, Medical College of Wisconsin, Indiana University, University of Colorado, Denver, Mayo Clinic, Weill Medical College of Cornell University, University of Florida

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Esophageal Strictures
Keywords
Esophageal Cancer, Dysphagia, Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EndoMAXX Endoluminal Valve Technology (EVT)
Arm Type
Experimental
Arm Description
EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
Arm Title
EndoMAXX
Arm Type
Active Comparator
Arm Description
EndoMAXX Fully Covered Esophageal Stent
Intervention Type
Device
Intervention Name(s)
EndoMAXX Endoluminal Valve Technology (EVT)
Other Intervention Name(s)
EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
Intervention Type
Device
Intervention Name(s)
EndoMAXX
Other Intervention Name(s)
EndoMAXX Fully Covered Esophageal Stent
Primary Outcome Measure Information:
Title
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
Description
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. = able to swallow some solid foods = able to swallow only semi solid foods = able to swallow liquids only = unable to swallow anything / total dysphagia
Time Frame
2 Weeks Following Treatment
Secondary Outcome Measure Information:
Title
GERD-HRQL
Description
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 = Symptoms noticeable but not bothersome = Symptoms noticeable and bothersome but not every day = Symptoms bothersome every day = Symptoms affect daily activity = Symptoms are incapacitating to do daily activities
Time Frame
4 Weeks Following Treament

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 years of age or older Patient (or legal representative) is able to understand and provide signed informed consent Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction. Exclusion Criteria: Patient is unwilling or unable to comply with the follow-up schedule Patient is contraindicated for endoscopic procedure for any reason Patient presents with esophagorespiratory fistula Patient has previously undergone esophageal stenting or esophagectomy Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm) Removal of stent is scheduled to occur within six months Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kulwinder DUA, MD
Organizational Affiliation
Medical College of WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30684601
Citation
Dua KS, DeWitt JM, Kessler WR, Diehl DL, Draganov PV, Wagh MS, Kahaleh M, Wong Kee Song LM, Khara HS, Khan AH, Aburajab MM, Ballard D, Forsmark CE, Edmundowicz SA, Brauer BC, Tyberg A, Buttar NS, Adler DG. A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). Gastrointest Endosc. 2019 Jul;90(1):64-74.e3. doi: 10.1016/j.gie.2019.01.013. Epub 2019 Jan 23.
Results Reference
derived

Learn more about this trial

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

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