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.

Evaluation of the Clinical Safety and Performance of an Investigational Multi-Hole™ Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Strictures Caused by Malignant Neoplasms
• Intervention / Treatment: Device: Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction

Detailed Description

The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Rabine; Phone Number: 484-896-5000; Email: sharon.rabine@olympus.com
• Study Contact Backup: Name: Jewel Gill; Email: Jewel.Gill@olympus.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and/or radiation) for malignant biliary obstruction

Clinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and/or dark urine)

Biochemical evidence (Tbili > 3mg/dL)

High quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)

≥ 18 years of age

Willing and able to provide informed consent

Exclusion Criteria:

• Participation in another investigational study within 90 days prior to consent

Intrahepatic metastases that extensively involve both lobes of the liver

Patients with a distal malignant biliary obstruction due to potential resectable disease

Strictures that could not be traversed by the delivery system

Perforation of any duct within the biliary tree

Presence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent

Active viral hepatitis

Life expectancy of < 3 months

Patient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources

Unwilling or unable to comply with the follow-up schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoints	Primary Outcome Measures 1. Clinical palliation of biliary obstruction maintenance of total bilirubin (Tbili) at 1-month follow-up < 3 mg/dL OR Tbili reduction by > 30% if the baseline value is > 3 mg/dL and absence of acute cholangitis AND absence of stent-related re-intervention until death, surgery, completion of data collection at 6-month follow-up visit, or withdrawal, whichever occurs first.	6 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Repositioning	Ability to successfully reposition or remove the stent, if required, at initial placement without clinically significant complications or technical difficulties	During the procedure
Stent Deployment	Stent Deployment Ability to deploy the stent in satisfactory position [During the procedure]	During the procedure
Symptoms	Symptoms of biliary obstruction (including jaundice, pruritus, right upper quadrant pain, fever, nausea, vomiting, and dark urine) at 1-, 3-, and 6-month follow-up visits and Tbili at 1-, 3-, and 6-month follow-up visits	6 months
Stent Patency	Stent patency rate at 1-, 3-, and 6-months post stent placement 6. Stent Occlusion or migration	6 months
6. Stent Occlusion or migration	Time to stent occlusion (days between stent placement and confirmation of stent obstruction), if applicable	6 Months
7. Occurrence and severity of device and procedure-related adverse events	Occurrence and severity of device and procedure-related adverse events	6 Months

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas
• Collaborators: Mayo Clinic; M.I.Tech Co., Ltd.
• Investigators: Principal Investigator: Ryan J Law, Doctor of Osteopathic Medicine, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Stent; Biliary Obstruction; Biliary Stent
• Other Study ID Numbers: 2025-GI-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes