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 ]
Freedom from major complications through the duration of the 1-week post-stent removal, defined as:
- Access site-related bleeding requiring transfusion;
- Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization;
- Surgery for access-site related perforation;
- Stent migration/dislodgement into the pseudocyst or enteral lumen;
- Tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal;
- Serious adverse event associated with the AXIOS stent and/or (index) implant procedure.
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