AXIOS Stent & Delivery System Study

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

April 30, 2013

Conditions
Pancreatic Pseudocyst(s)
Interventions
DEVICE

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."

Trial Locations (7)

10021

Cornell University, New York

19107

Thomas Jefferson University, Philadelphia

32256

Borland-Groover Clinic, Jacksonville

60637

University of Chicago Medical Center (UCMC), Chicago

80045

Unversity of Colorado Denver, Aurora

94115

California Pacific Medical Center (CPMC), San Francisco

951976669

Hospital Costa del Sol, Marbella

All Listed Sponsors
lead

Xlumena, Inc.

INDUSTRY

NCT01419769 - AXIOS Stent & Delivery System Study | Biotech Hunter | Biotech Hunter