NCT01699542

WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this of this study is to compare the safety and effectiveness of temporary indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of refractory anastomotic esophageal strictures

Conditions

• Refractory Anastomotic Esophageal Strictures

Interventions

Type	Name	Description
DEVICE	WallFlex Esophageal RX Fully Covered Stent	Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
DEVICE	Esophageal Bougie Dilator Per Investigator preference	Commercially available Esophageal Bougie Dilator Per Investigator preference

Timeline

• Start date: 2013-12-23
• Primary completion: 2016-09-25
• Completion: 2016-09-25
• First posted: 2012-10-03
• Last updated: 2021-06-28
• Results posted: 2021-06-28

Locations

4 sites across 3 countries: Brazil, Netherlands, Sweden