Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

AXIOS Stent & Delivery System Study

Lead Sponsor:

Xlumena, Inc.

Conditions:

Pancreatic Pseudocyst(s)

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug A...

Detailed Description

OBJECTIVE: To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudoc...

Eligibility Criteria

Inclusion

  • (patients must meet all 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 than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
  • Adherent to bowel wall, and
  • ≥70% fluid content
  • Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
  • Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion

  • (patients meeting any of the below criteria will be excluded from study)
  • \<18 or \>75 years of age
  • Pancreatic pseudocysts having the following characteristics:
  • Require nasocystic drainage,
  • \< 69% fluid content
  • 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.

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2013

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01419769

Start Date

August 1 2011

End Date

April 1 2013

Last Update

September 21 2015

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

California Pacific Medical Center (CPMC)

San Francisco, California, United States, 94115

2

Unversity of Colorado Denver

Aurora, Colorado, United States, 80045

3

Borland-Groover Clinic

Jacksonville, Florida, United States, 32256

4

University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States, 60637