EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Malignant Esophageal Strictures

Intervention / Treatment
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* Device: EndoMAXX Endoluminal Valve Technology (EVT)
* Device: EndoMAXX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoMAXX Endoluminal Valve Technology (EVT)<br>EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve | Device: EndoMAXX Endoluminal Valve Technology (EVT)<br> <br> * Other names: EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve;|
| Active Comparator: EndoMAXX<br>EndoMAXX Fully Covered Esophageal Stent | Device: EndoMAXX<br> <br> * Other names: EndoMAXX Fully Covered Esophageal Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 Weeks Following Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 Weeks Following Treament | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Dysphagia, Regurgitation