MedTrace Logo

Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)

NCT02460432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2017-04-11

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

Conditions

  • Biliary Neoplasms
  • Biliary Obstruction
  • Pancreatic Neoplasms

Interventions

DEVICE

Paclitaxel-eluting metal Stent

Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP

DEVICE

Covered Metal Stent

Insertion of ComVi Biliary Covered Stent using ERCP

Sponsors & Collaborators

  • Taewoong Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong Ki Lee, Ph.D MD · Gangnam Severance Hospital

  • Kyu Taek Lee, Ph.D MD · Samsung Medical Center

  • Sang Hyub Lee, Ph.D MD · Seoul National University Hospital

  • Don Haeng Lee, Ph.D MD · In Ha University Hospital

  • Jung Sik Choi, Ph.D MD · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-26
Completion
2016-12-26

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT02460432 on ClinicalTrials.gov