Biliary Strictures Caused by Malignant NeoplasmsNCT07715240
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.
A study testing Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction in people with Biliary Strictures Caused by Malignant Neoplasms, run by Olympus Corporation of the Americas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Strictures Caused by Malignant Neoplasms
- What is being tested?
- Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jewel Gill contact
About this study
Official title: 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.
Read the detailed description
The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
- Being tested
- Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
- Keywords
- Biliary Stent, Stent, Biliary Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary Stent for the Palliative Treatment of Malignant Biliary ObstructionDevice
Multi-hole anti-migration stent for biliary strictures produced by malignant neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
Primary Outcome Measures
- 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.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start31 Oct 2026 (estimated)
- Primary completion27 Feb 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Strictures Caused by Malignant NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, M.I.Tech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ryan J Law, Doctor of Osteopathic Medicine, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715240
- Sponsor's protocol ID
- 2025-GI-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No