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Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

NCT00945516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-10-19

No results posted yet for this study

Summary

The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.

Conditions

  • Bile Duct Disease

Interventions

DEVICE

Bona stent® (Flared end FCSEMS)

Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.

DEVICE

Hanarostent® (Anchoring FCSEMS)

Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Do Hyun Park, MD, PhD · Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • South Korea

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 NCT00945516 on ClinicalTrials.gov