Neoplasms

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Ear, Nose, and Throat Diseases

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Esophageal Neoplasms

Constriction, Pathologic

Deglutition Disorders

Esophageal Stenosis

Pathological Conditions, Anatomical

Esophageal Diseases

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

EndoMAXX Endoluminal Valve Technology (EVT)

EndoMAXX

Kulwinder DUA, MD

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).

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

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

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

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

Geisinger Clinic

Medical College of Wisconsin

Indiana University

University of Colorado, Denver

Mayo Clinic

Weill Medical College of Cornell University

University of Florida

Merit Medical Systems, Inc.

EndoMAXX EVT Fully Covered Esophageal Stent with Valve

EndoMAXX EVT

EndoMAXX EVT

EndoMAXX Fully Covered Esophageal Stent

EndoMAXX

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Casey Holland

1 patient was randomized but not treated and other patients are not included

Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment

EndoMAXX EVT Fully Covered Esophageal Stent with Valve

Results at week 4, number of patients analyzed differs from baseline due to inability to continue to follow the patients due to death or lost to follow up.

GERD-HRQL

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX	NCT02159898	Malignant Esoph...	EndoMAXX Endolu... EndoMAXX	18 Years -	Merit Medical Systems, Inc.
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX	NCT02159898	Malignant Esoph...	EndoMAXX Endolu... EndoMAXX	18 Years -	Merit Medical Systems, Inc.

Spots Global Cancer Trial Database for malignant esophageal strictures