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AXIOS Stent With Electrocautery Enhanced Delivery System

Primary Purpose

Pancreatic Pseudocyst(s)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AXIOS Stent with Electrocautery Enhanced Delivery System

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst(s) focused on measuring Pancreatic pseudocyst

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

AXIOS Stent with Electrocautery Enhanced Delivery System

Outcomes

Primary Outcome Measures

Safety/Adverse Event Outcome Measure 1

Freedom from access site-related bleeding requiring transfusion

Safety/Adverse Event Outcome Measure 2

Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization

Safety/Adverse Event Outcome Measure 3

Freedom from surgery for access-site related perforation

Safety/Adverse Event Outcome 4

Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen

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

Safety/Adverse Event Outcome Measure 6

Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

Secondary Outcome Measures

Stent Retention Outcome Measure

Stent Retention: The stent must remain in place for up to 60 days

Lumen Patency Outcome Measure

Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.

Technical Success Outcome Measure 1

Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System

Clinical Success Outcome Measure

Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days

Technical Success Outcome Measure 2

Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps

Full Information

NCT ID

NCT02146352

First Posted

May 13, 2014

Last Updated

September 2, 2015

Sponsor

Xlumena, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02146352

Brief Title

AXIOS Stent With Electrocautery Enhanced Delivery System

Official Title

AXIOS Stent With Electrocautery Enhanced Delivery System

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xlumena, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Pseudocyst(s)

Keywords

Pancreatic pseudocyst

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

AXIOS Stent with Electrocautery Enhanced Delivery System

Intervention Type

Device

Intervention Name(s)

AXIOS Stent with Electrocautery Enhanced Delivery System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety/Adverse Event Outcome Measure 1

Description

Freedom from access site-related bleeding requiring transfusion

Time Frame