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Dissolving stent could unblock bile ducts without extra surgery

NCT ID NCT04929821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new stent that slowly dissolves over time to open narrowed or blocked bile ducts. About 100 people with bile duct strictures will receive the stent during a routine procedure. Researchers will track safety, how well the stent works, and whether patients feel better.

What this could mean

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

Active substance
biodegradable balloon-expandable biliary stent
What this could lead to
If successful, this could provide a safer, temporary way to open blocked bile ducts without needing a second procedure to remove the stent.
What could go wrong
This is an early feasibility study with only 100 participants, so results may not apply to everyone. 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 100 people

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

Started

Oct 2017

Expected to finish

Jul 2026

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: * 1\) A subject with a biliary stricture may be entered into the study with: at least one of the following: * Benign fibrotic distal bile duct obstruction * Duct occlusion caused by cholelithiasis * A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic liver enzymes levels * Ductal anastomotic strictures * Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla. * Neoplasm diagnosed on clinical and imaging findings * Post-ERCP pancreatitis * Obstructive jaundice with evidence of pruritus, tea color urine and pale stool * Abnormal Bilirubin rate or * A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or * A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old Exclusion Criteria: Patients, male or female, presenting with the following criteria may be included: 1. Subject is unwilling to comply with the follow-up schedule 2. Life expectancy \< 12 m, 3. Inability to pass a guidewire through stricture 4. Contra-indication for endoscopy or interventional radiology 5. History of allergic reactions to one of the compounds of investigational product. 6. Subject is unable or refuses to give informed consent 7. Subject is pregnant or breastfeeding 8. Patient under tutorship 9. Currently participating in another trial before reaching first endpoint. 10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma 11. Patient need additional biliary stenting with another device than the study device. \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 3 countries. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIG Hospitals (Asian Institute of Gastroenterology)

    RECRUITING

    Hyderabad, 500032, India

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Sunway Medical Centre

    RECRUITING

    Kuala Lumpur, 47500, Malaysia

  • The Prince of Wales Hospital

    ENROLLING_BY_INVITATION

    Hong Kong, Hong Kong

  • University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Universityi Kebangsaan Malaysia (UKM)

    COMPLETED

    Kuala Lumpur, 56000, Malaysia

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