Clinical trial NCT02159898: EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Esophageal Strictures
Keywords: Esophageal Cancer
Dysphagia
Regurgitation
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
name: Medical College of Wisconsin
name: Indiana University
name: University of Colorado, Denver
name: Mayo Clinic
name: Weill Medical College of Cornell University
name: University of Florida
First posted: 2014-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 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.

Primary outcomes:
measure: Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
timeFrame: 2 Weeks Following Treatment
Secondary outcomes:
measure: GERD-HRQL
timeFrame: 4 Weeks Following Treament
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of WI
name: Kulwinder DUA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dua KS, DeWitt JM, Kessler WR, Diehl DL, Draganov PV, Wagh MS, Kahaleh M, Wong Kee Song LM, Khara HS, Khan AH, Aburajab MM, Ballard D, Forsmark CE, Edmundowicz SA, Brauer BC, Tyberg A, Buttar NS, Adler DG. A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). Gastrointest Endosc. 2019 Jul;90(1):64-74.e3. doi: 10.1016/j.gie.2019.01.013. Epub 2019 Jan 23.