Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent (MIRA-cover)

March 9, 2020 updated by: Taewoong Medical Co., Ltd.

Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University Hospital Cheonan
      • Daegu, Korea, Republic of
        • Catholic University of Daegu School of Medicine
      • Seoul, Korea, Republic of, 135-720
        • Kangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
  • Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion Criteria:

  • Patient who have life expectancy under 3 months
  • Patient who have severe metastasis of Liver or whole body
  • Patient who previously had surgical biliary drainage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel ElutingCovered Metal Stent
Device: Biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover Biliary Stent
  • Niti-S Biliary Stent
Active Comparator: Covered Metal Stent
Device: Biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover Biliary Stent
  • Niti-S Biliary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accumulative Patency Rate
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Accumulative Survival Rate
Time Frame: 6 months
6 months
Complications
Time Frame: 6 months
6 months
Possibility of Other Treatment after Obstruction
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taewoong Medical Co., Ltd.

Investigators

  • Study Chair: Dong Ki Lee, Ph.D, Kangnam Severance Hospital
  • Principal Investigator: Ho Gak Kim, Catholic University of Daegu School of Medicine
  • Principal Investigator: Sang Heum Park, Soon Chun Hyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 15, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRA-cover

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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