EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Completed · Not applicable

Conditions studied: Malignant Esophageal Strictures

In brief

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).

Key facts

Study ID

NCT02159898

Run by

Merit Medical Systems, Inc.

People needed

60

Starts

2015-01-01

Expected to finish

2016-12-01

Last updated by the study team

2018-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Weill Cornell Medical College — New York, New York, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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