CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
Partially covered SEMS +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/NCT01661686
NCT01661686N/ACompleted
CompareCT.gov

A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

Foundation for Liver Research·interventional·Posted Aug 9, 2012·Updated Oct 3, 2019

In Brief

A clinical study evaluating Partially covered SEMS and Fully covered SEMS for Esophageal Cancer and Esophageal Stenosis. Completed, enrolled 98 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Esophageal Stenosis
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2012
Enrollment StartJul 1, 2012
Primary CompletionApr 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.9 years ago

Interventions

Partially covered SEMSdevice

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Fully covered SEMSdevice

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available