AXIOS Stent With Electrocautery Enhanced Delivery System

Not Applicable

Completed

• Conditions: Pancreatic Pseudocyst(s)
• Interventions: Device: AXIOS Stent with Electrocautery Enhanced Delivery System

• Registration Number: NCT02146352
• Lead Sponsor: Xlumena, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Study Start: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2015-09
• Results First Submitted: 2015-09-02
• Results First Submitted QC: 2015-09-02
• Last Update Submitted: 2015-09-02
• Results First Posted: 2015-10-02
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age between 18 and 75 years old, male or female

2. Eligible for endoscopic intervention

3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage

4. 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

5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.

6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion Criteria

1. The fluid collection to be drained is an immature pseudocyst

2. The fluid collection to be drained is a cystic neoplasm

3. The fluid collection to be drained is a pseudoaneurysm

4. The fluid collection to be drained is a duplication cyst

5. The fluid collection to be drained is a non-inflammatory fluid collection

6. There is more than one pseudocyst requiring drainage

7. Abnormal coagulation:

   • INR > 1.5 and not correctable
   • presence of a bleeding disorder
   • platelets < 50,000/mm3

8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).

9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)

10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.

11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.

12. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	AXIOS Stent with Electrocautery Enhanced Delivery System	AXIOS Stent with Electrocautery Enhanced Delivery System

Primary Outcome Measures

Name	Time	Method
Safety/Adverse Event Outcome Measure 3	Index procedure through 1-week post-stent removal	Freedom from surgery for access-site related perforation
Safety/Adverse Event Outcome Measure 2	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 6	Index procedure through 1-week post-stent removal	Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure
Safety/Adverse Event Outcome Measure 5	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 1	Index procedure through 1-week post-stent removal	Freedom from access site-related bleeding requiring transfusion
Safety/Adverse Event Outcome 4	Index procedure through 1-week post-stent removal	Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen

Secondary Outcome Measures

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

Trial Locations

Locations (8)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States