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X-MAS Biliary Study With Covered Biliary Stent

NCT01899976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-04-13

No results posted yet for this study

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.

Conditions

  • Biliary Tract Cancer

Interventions

DEVICE

X-Suit NIR Covered Biliary Stent

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • Peter D Siersema, Prof. · University Medical Center Utrecht, Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-11-13
Completion
2017-11-13

Countries

  • Belgium
  • Israel
  • Netherlands

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 NCT01899976 on ClinicalTrials.gov