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EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

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ClinicalTrials.gov Identifier: NCT02159898
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Geisinger Clinic
Medical College of Wisconsin
Indiana University
University of Colorado, Denver
Mayo Clinic
Weill Medical College of Cornell University
University of Florida
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Malignant Esophageal Strictures Device: EndoMAXX Endoluminal Valve Technology (EVT) Device: EndoMAXX Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EndoMAXX Endoluminal Valve Technology (EVT)
EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
 Device: EndoMAXX Endoluminal Valve Technology (EVT)
Other Name: EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
Active Comparator: EndoMAXX
EndoMAXX Fully Covered Esophageal Stent
 Device: EndoMAXX
Other Name: EndoMAXX Fully Covered Esophageal Stent


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159898


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Merit Medical Systems, Inc.
Geisinger Clinic
Medical College of Wisconsin
Indiana University
University of Colorado, Denver
Mayo Clinic
Weill Medical College of Cornell University
University of Florida
Investigators
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Principal Investigator: Kulwinder DUA, MD Medical College of WI
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02159898    
Other Study ID Numbers: ESO-P3-12-02
First Posted: June 10, 2014    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Merit Medical Systems, Inc.:
Esophageal Cancer
Dysphagia
Regurgitation
Additional relevant MeSH terms:
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Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases