AXIOS Stent With Electrocautery Enhanced Delivery System

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 Overview

• Status: Completed
• Conditions: Pancreatic Pseudocyst(s)
• Intervention / Treatment: Device: AXIOS Stent with Electrocautery Enhanced Delivery System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Baptist Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; AXIOS Stent with Electrocautery Enhanced Delivery System	Device: AXIOS Stent with Electrocautery Enhanced Delivery System; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xlumena, Inc.
• Investigators: Principal Investigator: Steven A Edmundowicz, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pancreatic pseudocyst
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Pseudocyst
• Other Study ID Numbers: CP201303