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A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study. Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations: * Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP) * Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery * Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak * Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy * Group E: Other - In subjects with other indications
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Evangelisches Krankenhaus Dusseldorf
Düsseldorf, Germany
Asian Institute of Gastroenterology
Somājigūda, Hyderabad, India
Erasmus Medical Center
Rotterdam, Netherlands
Start Date
February 1, 2015
Primary Completion Date
September 1, 2016
Completion Date
September 1, 2016
Last Updated
March 21, 2017
246
ACTUAL participants
The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
DEVICE
Lead Sponsor
Boston Scientific Corporation
NCT05664074
NCT02602574
NCT02308891
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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