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WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture

NCT01699542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-06-28

Study results available
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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

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Peter D. Siersema, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-23
Primary Completion
2016-09-25
Completion
2016-09-25

Countries

  • Brazil
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699542 on ClinicalTrials.gov