CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
Niti-S Biliary ComVi 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/NCT02930252
NCT02930252N/ACompleted
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Covered Versus Uncovered Self-conformable Metal Stent for Palliation of Primary Malignant Extra-hepatic Biliary Strictures: a Randomized Multicenter Study

Azienda USL 1 Imperiese·interventional·Posted Oct 12, 2016·Updated Oct 12, 2016

In Brief

A clinical study evaluating Niti-S Biliary ComVi Stent and Niti-S stent (D type) for Biliary Cancer. Completed, enrolled 170 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Cancer
CountriesItaly
CollaboratorsOspedali Riuniti Marche Nord, Pesaro, Italy, NOCSAE Hospital, Modena, Italy, University of Siena, Papa Giovanni XXIII Hospital

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 12, 2016
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2015
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.7 years ago

Interventions

Niti-S Biliary ComVi Stentdevice

Endoscopic placement of biliary fully covered metal stents

Niti-S stent (D type)device

Endoscopic placement of biliary uncovered metal stent