AXIOS Stent With Electrocautery Enhanced Delivery System

Pancreatic Pseudocyst(s) Clinical Trial

Official title:

AXIOS Stent With Electrocautery Enhanced Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146352
• Other study ID #: CP201303
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: September 2, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Xlumena, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Pseudocyst
• Pancreatic Pseudocyst(s)

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Baptist Medical Center	Jacksonville	Florida
United States	Florida Hospital	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Xlumena, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/Adverse Event Outcome Measure 1	Freedom from access site-related bleeding requiring transfusion	Index procedure through 1-week post-stent removal	Yes
Primary	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	Yes
Primary	Safety/Adverse Event Outcome Measure 3	Freedom from surgery for access-site related perforation	Index procedure through 1-week post-stent removal	Yes
Primary	Safety/Adverse Event Outcome 4	Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen	Index procedure through 1-week post-stent removal	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Stent Retention Outcome Measure	Stent Retention: The stent must remain in place for up to 60 days	30 or 60 days post-procedure	No
Secondary	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	No
Secondary	Technical Success Outcome Measure 1	Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System	Index Procedure	No
Secondary	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	No
Secondary	Technical Success Outcome Measure 2	Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps	30 or 60 Day Post-procedure	No