Clinical Trial

The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.

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Summary
The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-15.
Trial Details
NCT Number NCT07715240
Lead Sponsor Olympus Corporation of the Americas
Collaborators: Mayo Clinic, M.I.Tech Co., Ltd.
Conditions Biliary Strictures Caused by Malignant Neoplasms
Enrollment 66 participants
Start Date 2026-10-31
Primary Completion 2027-02-27 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21