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Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

NCT01041612 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-10-21

No results posted yet for this study

Summary

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Conditions

Interventions

DEVICE

PTFE Covered ComVi [full covered] Biliary Stent

The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

DEVICE

PTFE Covered ComVi [full covered] Biliary Stent

The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

Sponsors & Collaborators

  • Taewoong Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong Ki Lee, PH.D · Gangnam Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01041612 on ClinicalTrials.gov