AXIOS Stent With Electrocautery Enhanced Delivery System

Study Overview
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Brief Summary
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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.

Official Title
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AXIOS Stent With Electrocautery Enhanced Delivery System

Conditions
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Pancreatic Pseudocyst(s)

Intervention / Treatment
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* Device: AXIOS Stent with Electrocautery Enhanced Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years old, male or female Eligible for endoscopic intervention Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage Symptomatic pancreatic pseudocyst having the following characteristics: Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound). Adherent to bowel wall, and ≥70% fluid content Patient understands the study requirements and the treatment procedures and provides written Informed Consent. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study. Exclusion Criteria: The fluid collection to be drained is an immature pseudocyst The fluid collection to be drained is a cystic neoplasm The fluid collection to be drained is a pseudoaneurysm The fluid collection to be drained is a duplication cyst The fluid collection to be drained is a non-inflammatory fluid collection There is more than one pseudocyst requiring drainage Abnormal coagulation: INR > 1.5 and not correctable presence of a bleeding disorder platelets < 50,000/mm3 Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>AXIOS Stent with Electrocautery Enhanced Delivery System | Device: AXIOS Stent with Electrocautery Enhanced Delivery System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Adverse Event Outcome Measure 1 | Freedom from access site-related bleeding requiring transfusion | 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 | Index procedure through 1-week post-stent removal | 
| Safety/Adverse Event Outcome Measure 3 | Freedom from surgery for access-site related perforation | Index procedure through 1-week post-stent removal | 
| Safety/Adverse Event Outcome 4 | Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen | 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 | 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 | Index procedure through 1-week post-stent removal | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic pseudocyst