Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
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ClinicalTrials.gov Identifier: NCT00945516 |
Recruitment Status
:
Completed
First Posted
: July 24, 2009
Last Update Posted
: October 19, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bile Duct Disease | Device: Bona stent® (Flared end FCSEMS) Device: Hanarostent® (Anchoring FCSEMS) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | May 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Flared end FCSEMS
Flared end FCSEMS will be inserted for the benign bile duct stricture.
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Device: Bona stent® (Flared end FCSEMS)
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
Other Name: Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)
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Active Comparator: Anchoring FCSEMS
Anchoring FCSEMS will be inserted for benign bile duct stricture
|
Device: Hanarostent® (Anchoring FCSEMS)
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Other Name: Hanarostent® (M.I.Tech, Seoul, Korea)
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- Stent migration rate [ Time Frame: one year ]
- Feasibility (Technical success rate and functional success rate) [ Time Frame: one year ]
- Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure) [ Time Frame: one year ]
- Removability [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient over 18 years old
- Patient with benign bile duct stricture
Exclusion Criteria:
- No written informed consent
- Malignant biliary obstruction
- Patients with uncorrectable severe coagulopathy
- Patients with severe cardiopulmonary disease precluding sedation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945516
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138-736 |
Study Director: | Do Hyun Park, MD, PhD | Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jung Sin Lee / the director of a center, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00945516 History of Changes |
Other Study ID Numbers: |
2009-0233 |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | October 19, 2010 |
Last Verified: | October 2010 |
Keywords provided by Asan Medical Center:
Metal stent Bile duct stricture Stent migration |
Feasibility Safety Removability |
Additional relevant MeSH terms:
Constriction, Pathologic Bile Duct Diseases Pathological Conditions, Anatomical Biliary Tract Diseases Digestive System Diseases |