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 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025-GI-01
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Biliary Stent; Stent; Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Stent Repositioning

  During the procedure

• Stent Deployment

  During the procedure

• Symptoms

  6 months

Interventions

Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead
• Mayo Clinic: collaborator
• M.I.Tech Co., Ltd.: collaborator

Study Officials

• Ryan J Law, Doctor of Osteopathic Medicine

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Rabine

CONTACT

484-896-5000; sharon.rabine@olympus.com

Jewel Gill

CONTACT

Jewel.Gill@olympus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share