WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture (E7025)

Boston Scientific

Status: Completed

Conditions: Refractory Anastomotic Esophageal Strictures

Treatments: Device: WallFlex Esophageal RX Fully Covered Stent; Device: Esophageal Bougie Dilator Per Investigator preference

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699542

90913904

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Metal Stent

Active Comparator group

Description:

The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.

Treatment:

Device: WallFlex Esophageal RX Fully Covered Stent

Bougie Dilation

Active Comparator group

Description:

Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.

Treatment:

Device: Esophageal Bougie Dilator Per Investigator preference