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New stent aims to ease Cancer-Related bile duct blockages without surgery

NCT ID NCT07715240

Symptom relief Sponsor: Olympus Corporation of the Americas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This trial tests a new type of stent designed to open blocked bile ducts in people with cancer that cannot be cured. The stent is placed during a routine endoscopic procedure and has special holes to help keep it in place. Researchers are checking whether it safely relieves jaundice and other symptoms for up to six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a multi-hole anti-migration biliary stent
What this could lead to
If successful, this stent could offer a safer, more effective way to relieve jaundice and other symptoms in people with bile duct blockages from cancer.
What could go wrong
This is a small, early-stage study focused on safety and performance, so the stent may not work better than existing options. Risks include infection, stent migration, or blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary strictures caused by malignant neoplasms

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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