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

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

Inclusion Criteria:Esophageal anastomotic stricture post esophagectomy (esophagogastric strictures).

• Esophagectomy performed at the same institution where patient enrollment and follow-up is planned.
• Two dilations to at least 16 mm in diameter since esophagectomy.
• 1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months of 1st dilation to 16mm.
• Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
• Unable to pass a standard endoscope (approx. 9.8 mm diameter).
• Age 18 years or older.
• Willing and able to comply with the study procedures and provide

Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter.

• Dysphagia related to motility disorder.
• Non-anastomotic esophageal strictures.
• Esophagocolonic strictures.
• Planned adjuvant radiation therapy post esophagectomy.
• Prior esophageal stent placements post esophagectomy.
• Active erosive esophagitis.
• Sensitivity to any components of the stent or delivery system.
• Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
• Stricture length > 5 cm.