NCT02802020

WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients With Chronic Pancreatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.

Detailed description

This study is a prospective, single arm, pre-approval study. Treatment of up to 92 patients will take place at up to 15 clinical centers. Patient who meet all eligibility criteria will receive the WallFlex Pancreatic stent for up to 6 months stent indwell and 6 months follow-up after stent removal.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DEVICE	Pancreatic fully-covered self-expanding metal stent (FCSEMS)	The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Timeline

• Start date: 2017-01-25
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2016-06-16
• Last updated: 2022-11-21
• Results posted: 2022-11-21

Locations

11 sites across 6 countries: United States, Belgium, Canada, India, Italy, Netherlands

Regulatory

• FDA-regulated device study