EndoMAXX EVT Compared to EndoMAXX
Conditions
Malignant Esophageal Strictures
Conditions: official terms
Constriction, Pathologic - Esophageal Stenosis
Conditions: Keywords
Esophageal Cancer, Dysphagia, Regurgitation
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: EndoMAXX EVT Type: Device
Name: EndoMAXX Type: Device
Overall Status
Recruiting
Summary
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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

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 anticipated 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.
Locations
University of Colorado Denver
Aurora, Colorado, United States
Status: Recruiting
Contact: Alissa Bults - 303-724-6670
University of Florida
Gainsville, Florida, United States
Status: Recruiting
Contact: April Goddard, PAC - 352-273-9474
Indiana University
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Anita Gupta - 317-948-9227
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Lori Lutzke, RN - 507-255-6930
Weill Cornell Medical College
New York, New York, United States
Status: Not yet recruiting
Contact: Monica Gaidhane, MD - 646-962-4796
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Heather Albertson, RN - 570-271-6856
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Sheila Therfelder - 414-955-6804
Start Date
January 2015
Completion Date
January 2016
Sponsors
Merit Medical Systems, Inc.
Source
Merit Medical Systems, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page