Clinical trial NCT02146352: AXIOS Stent With Electrocautery Enhanced Delivery System
Official title: AXIOS Stent With Electrocautery Enhanced Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Pseudocyst(s)
Keywords: Pancreatic pseudocyst
Lead sponsor: Xlumena, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety/Adverse Event Outcome Measure 1
timeFrame: Index procedure through 1-week post-stent removal
measure: Safety/Adverse Event Outcome Measure 2
timeFrame: Index procedure through 1-week post-stent removal
measure: Safety/Adverse Event Outcome Measure 3
timeFrame: Index procedure through 1-week post-stent removal
measure: Safety/Adverse Event Outcome 4
timeFrame: Index procedure through 1-week post-stent removal
measure: Safety/Adverse Event Outcome Measure 5
timeFrame: Index procedure through 1-week post-stent removal
measure: Safety/Adverse Event Outcome Measure 6
timeFrame: Index procedure through 1-week post-stent removal
Secondary outcomes:
measure: Stent Retention Outcome Measure
timeFrame: 30 or 60 days post-procedure
measure: Lumen Patency Outcome Measure
timeFrame: 30 and/or 60 days post-procedure
measure: Technical Success Outcome Measure 1
timeFrame: Index Procedure
measure: Clinical Success Outcome Measure
timeFrame: 30 or 60 days post-procedure
measure: Technical Success Outcome Measure 2
timeFrame: 30 or 60 Day Post-procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine
name: Steven A Edmundowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: