EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:January 2015
End Date:December 2016

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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

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).


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.
We found this trial at
7
sites
Rochester, Minnesota 55905
Principal Investigator: Louis Wong Kee Song, MD
Phone: 507-255-6930
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Rochester, MN
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: William Kessler, MD
Phone: 317-948-9227
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Norio Fukami, MD
Phone: 303-724-6670
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: David Diehl, MD
Phone: 570-271-6856
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Kulwinder Dua, MD
Phone: 414-955-6804
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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New York, New York 10021
Principal Investigator: Michel Kahaleh, MD
Phone: 646-962-4796
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New York, NY
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