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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.

NCT07715240 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-21

No results posted yet for this study

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.

Conditions

  • Biliary Strictures Caused by Malignant Neoplasms

Interventions

DEVICE

Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction

Multi-hole anti-migration stent for biliary strictures produced by malignant neoplasms

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • M.I.Tech Co., Ltd.

    collaborator UNKNOWN

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Ryan J Law, Doctor of Osteopathic Medicine · Mayo Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-02-27
Completion
2028-05-30
FDA Device
Yes

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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 NCT07715240 on ClinicalTrials.gov