30
Participants
Start Date
August 31, 2011
Primary Completion Date
June 30, 2012
Study Completion Date
April 30, 2013
AXIOS Stent & Delivery System
"The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
Cornell University, New York
Thomas Jefferson University, Philadelphia
Borland-Groover Clinic, Jacksonville
University of Chicago Medical Center (UCMC), Chicago
Unversity of Colorado Denver, Aurora
California Pacific Medical Center (CPMC), San Francisco
Hospital Costa del Sol, Marbella
Xlumena, Inc.
INDUSTRY