A Prospective Multi-Center Registry using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct

Boston Scientific Corporation0 个研究点目标入组 46 人开始时间: 待定最近更新: 2021年11月24日

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•Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation, provided no exclusion criterion is met.
•1. Subjects age 18 or older.
•2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
•3. Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study.
•4. Subjects satisfying at least one of the following clinical presentations:
•a. high risk of acute pancreatitis post ERCP
•b. impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery
•c. need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
•d. need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy

•1. Subjects for whom endoscopic techniques are contraindicated.
•2. Subjects with known sensitivity to any components of the stents or delivery systems.
•3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
•4. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
•5. Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.

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