Clinical Trial: AXIOS Stent With Electrocautery Enhanced Delivery System

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: AXIOS Stent With Electrocautery Enhanced Delivery System

Brief Summary: 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.

Detailed Summary:
Sponsor: Xlumena, Inc.

Current Primary Outcome:

• Safety/Adverse Event Outcome Measure 1 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from access site-related bleeding requiring transfusion
• Safety/Adverse Event Outcome Measure 2 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
• Safety/Adverse Event Outcome Measure 3 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from surgery for access-site related perforation
• Safety/Adverse Event Outcome 4 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen
• Safety/Adverse Event Outcome Measure 5 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal
• Safety/Adverse Event Outcome Measure 6 [ Time Frame: Index procedure through 1-week post-stent removal ]
  Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

Original Primary Outcome: Safety/Adverse Event Outcome Measure [ Time Frame: Index procedure through 1-week post-stent removal ]

Current Secondary Outcome:

• Stent Retention Outcome Measure [ Time Frame: 30 or 60 days post-procedure ]
  Stent Retention: The stent must remain in place for up to 60 days
• Lumen Patency Outcome Measure [ Time Frame: 30 and/or 60 days post-procedure ]
  Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.
• Technical Success Outcome Measure 1 [ Time Frame: Index Procedure ]
  Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System
• Clinical Success Outcome Measure [ Time Frame: 30 or 60 days post-procedure ]
  Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days
• Technical Success Outcome Measure 2 [ Time Frame: 30 or 60 Day Post-procedure ]
  Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps

Original Secondary Outcome:

• Stent Retention Outcome Measure [ Time Frame: 30 or 60 days post-procedure ]
  Stent Retention: The stent must remain in place for up to 60 days
• Lumen Patency Outcome Measure [ Time Frame: 30 and/or 60 days post-procedure ]
  Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.
• Technical Success Outcome Measure [ Time Frame: Index Procedure and at 30 or 60 days post-procedure ]
  Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System and successful removal of the AXIOS stent using a standard endoscopic snare or forceps.
• Clinical Success Outcome Measure [ Time Frame: 30 or 60 days post-procedure ]
  Clinical success: At least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days or 60 days.

Information By: Xlumena, Inc.

Dates:
Date Received: May 13, 2014
Date Started: June 2014
Date Completion:
Last Updated: September 2, 2015
Last Verified: September 2015