WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

NCT ID: NCT01699542

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-23
• Study Completion Date: 2016-09-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metal Stent

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

Group Type: ACTIVE_COMPARATOR

WallFlex Esophageal RX Fully Covered Stent

Intervention Type: DEVICE

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

Bougie Dilation

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

Group Type: ACTIVE_COMPARATOR

Esophageal Bougie Dilator Per Investigator preference

Intervention Type: DEVICE

Commercially available Esophageal Bougie Dilator Per Investigator preference

Interventions

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

Intervention Type: DEVICE

Esophageal Bougie Dilator Per Investigator preference

Commercially available Esophageal Bougie Dilator Per Investigator preference

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter D. Siersema, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Instituto do Cancer do Estado de Sao Paulo

São Paulo, , Brazil

Erasmus Medical Center

Rotterdam, CE, Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Karolinska Universitets Sjukhuset

Stockholm, , Sweden

Countries

Brazil; Netherlands; Sweden

Other Identifiers

90913904

Identifier Type: -

Identifier Source: org_study_id