NCT01899976

X-MAS Biliary Study With Covered Biliary Stent

A Non-Randomized, Multi-Center, Prospective, Single Arm Clinical Study of the X-SUIT NIR® Covered Biliary Metallic Stent for Palliation of Malignant Strictures in the Biliary Tree Via Endoscopic Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.

Detailed description

This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach. Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process. The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DEVICE	X-Suit NIR Covered Biliary Stent

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-11-13
• Completion: 2017-11-13
• First posted: 2013-07-16
• Last updated: 2022-04-13

Locations

9 sites across 3 countries: Belgium, Israel, Netherlands