Overview

This trial is active, not recruiting.

Condition refractory anastomotic esophageal strictures
Treatments wallflex esophageal rx fully covered stent, esophageal bougie dilator per investigator preference
Phase phase 4
Sponsor Boston Scientific Corporation
Start date April 2013
End date September 2016
Trial size 44 participants
Trial identifier NCT01699542, CDM00049674

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
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
(Active Comparator)
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
esophageal bougie dilator per investigator preference
Commercially available Esophageal Bougie Dilator Per Investigator preference

Primary Outcomes

Measure
Number of procedures
time frame: 12 months

Secondary Outcomes

Measure
Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture
time frame: 12 months
Technical stent removal success defined as the ability to remove the stent without complications.
time frame: 12 months
Patient's satisfaction with therapy
time frame: 12 months
Patient's report of pain
time frame: 12 months
Quality Of Life (QOL): Improvement in EQ-5D-5L
time frame: 12 months
Patient diary to assess dysphagia scores
time frame: 12 months
Health Economic Endpoint
time frame: 12 months
Health Economic Endpoint
time frame: 12 months
Health Economic Endpoint
time frame: 12 months
Title: Health Economic Endpoint
time frame: 12 months
Safety Endpoint
time frame: 12 months
Efficacy Endpoint
time frame: 12 months
Efficacy Endpoint
time frame: 12 months
Efficacy Endpoint
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Peter D. Siersema, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.