AXIOS Stent With Electrocautery Enhanced Delivery System

NCT02146352 | Completed Results DMC

• 1 other identifier: CP201303
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

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.

Conditions

Pancreatic Pseudocyst(s)

Keywords

Pancreatic pseudocyst

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Stent Retention Outcome Measure

  30 or 60 days post-procedure

• Lumen Patency Outcome Measure

  30 and/or 60 days post-procedure

• Technical Success Outcome Measure 1

  Index Procedure

• Clinical Success Outcome Measure

  30 or 60 days post-procedure

• Technical Success Outcome Measure 2

  30 or 60 Day Post-procedure

Study Arms (1)

Treatment

EXPERIMENTAL

AXIOS Stent with Electrocautery Enhanced Delivery System

Device: AXIOS Stent with Electrocautery Enhanced Delivery System

Interventions

AXIOS Stent with Electrocautery Enhanced Delivery System DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xlumena, Inc.: lead

Study Sites (8)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32256, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Lina Ginnetti
• Organization: Boston Scientific Corp.

Lina.Ginnetti@bsci.com

508-683-4512

Study Officials

• Steven A Edmundowicz, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 2, 2015
• Results First Posted: October 2, 2015

Record last verified: 2015-09

Locations

US (8)