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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07715240

Enrollment

Registered

2026-07-20

Start date

2026-10-31

Completion date

2028-05-30

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Strictures Caused by Malignant Neoplasms

Keywords

Biliary Stent, Stent, Biliary Obstruction

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.

Detailed description

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

Interventions

DEVICEBiliary Stent for the Palliative Treatment of Malignant Biliary Obstruction

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Endpoints	6 Month	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.

Contacts

CONTACTSharon Rabine

sharon.rabine@olympus.com484-896-5000

CONTACTJewel Gill

Jewel.Gill@olympus.com

PRINCIPAL_INVESTIGATORRyan J Law, Doctor of Osteopathic Medicine

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026