CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
WallFlex Esophageal RX Fully Covered Stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01699542
NCT01699542N/ACompleted
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Oct 3, 2012·Updated Jun 28, 2021

In Brief

A clinical study evaluating WallFlex Esophageal RX Fully Covered Stent and Esophageal Bougie Dilator Per Investigator preference for Refractory Anastomotic Esophageal Strictures. Completed, enrolled 18 participants across 4 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Anastomotic Esophageal Strictures
CountriesBrazil, Netherlands, Sweden
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2012
Enrollment StartDec 23, 2013
Primary CompletionSep 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.7 years ago

Interventions

WallFlex Esophageal RX Fully Covered Stentdevice

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

Esophageal Bougie Dilator Per Investigator preferencedevice

Commercially available Esophageal Bougie Dilator Per Investigator preference