EndoMAXX EVT Compared to EndoMAXX
This trial has been completed.
|Condition||malignant esophageal strictures|
|Treatments||endomaxx evt, endomaxx|
|Sponsor||Merit Medical Systems, Inc.|
|Start date||January 2015|
|End date||October 2016|
|Trial size||60 participants|
|Trial identifier||NCT02159898, ESO-P3-12-02|
This is a prospective, single blinded, randomized study of EndoMAXX 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 EVT Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aurora, CO||University of Colorado Denver||completed|
|Gainsville, FL||University of Florida||completed|
|Indianapolis, IN||Indiana University||completed|
|Rochester, MN||Mayo Clinic||completed|
|New York, NY||Weill Cornell Medical College||completed|
|Danville, PA||Geisinger Medical Center||completed|
|Milwaukee, WI||Medical College of Wisconsin||completed|
|Intervention model||parallel assignment|
EndoMAXX EVT Fully Covered Esophageal Stent with Valve
EndoMAXX Fully Covered Esophageal Stent
Mellow and Pinkas Dysphagia Score
time frame: 2 Weeks Following Treatment
time frame: 4 Weeks Following Treament
time frame: 4 Weeks Following Treatment
time frame: 6 Months
All participants at least 18 years old.
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.
|Official title||Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX EVT Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction|
|Principal investigator||Kulwinder DUA, MD|
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