The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
University of Colorado Denver
Aurora, Colorado, United States
Baptist Medical Center
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Safety/Adverse Event Outcome Measure 1
Freedom from access site-related bleeding requiring transfusion
Time frame: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 2
Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Time frame: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 3
Freedom from surgery for access-site related perforation
Time frame: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome 4
Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
Time frame: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 5
Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal
Time frame: Index procedure through 1-week post-stent removal
Safety/Adverse Event Outcome Measure 6
Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure
Time frame: Index procedure through 1-week post-stent removal
Stent Retention Outcome Measure
Stent Retention: The stent must remain in place for up to 60 days
Time frame: 30 or 60 days post-procedure
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University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University in St. Louis
St Louis, Missouri, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Lumen Patency Outcome Measure
Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.
Time frame: 30 and/or 60 days post-procedure
Technical Success Outcome Measure 1
Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System
Time frame: Index Procedure
Clinical Success Outcome Measure
Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days
Time frame: 30 or 60 days post-procedure
Technical Success Outcome Measure 2
Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps
Time frame: 30 or 60 Day Post-procedure