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Dissolving stent could spare patients a second procedure

NCT ID NCT04708288

Disease control Sponsor: QualiMed Innovative Medizinprodukte GmbH Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study follows about 200 people who receive a special stent that naturally dissolves over time to open blocked bile or pancreatic ducts. The stent is designed to avoid the need for a second procedure to remove it. Researchers track safety and how well the stent keeps the duct open during routine care.

What this could mean

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

Active substance
ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
What this could lead to
If successful, this biodegradable stent could offer a safer, temporary way to open blocked ducts without needing a second procedure to remove it.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Risks include pancreatitis, bleeding, infection, or stent migration.

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.

Participants

About 198 people

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

Started

Oct 2020

Expected to finish

Dec 2027

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.

Who is studied

Patients that will respect the inlcusion criteria will be enrolled in the study.

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: * Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines * Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted) Exclusion Criteria: * Age \< 18 y * Inability to understand the purpose of the study or refusal to cooperate * Not available for routine follow-up visits * Pregnancy * Currently participating in a confounding trial before reaching first endpoint.

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Conditions

The condition(s) this trial relates to.

cholestasis

As listed by the trial registrant

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

Obstructed biliary and pancreatic duct

How to take part

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

  1. The places running it

    3 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

  • AUSL Romagna Ospedale Morgagni - Pierantoni

    COMPLETED

    Forlì, 47121, Italy

  • Emek Medical Center

    COMPLETED

    Afula, 1834111, Israel

  • Endoscopy Unit, Humanitas Research Hospital

    ACTIVE_NOT_RECRUITING

    Rozzano, Milano, 20089, Italy

  • Evangelisches Krankenhaus Düsseldorf

    RECRUITING

    Düsseldorf, 40217, Germany

  • Gastroenterology and Digestive Endoscopy Unit Fondazione I.R.C.C.S. Policlinico San Matteo

    ACTIVE_NOT_RECRUITING

    Pavia, 27100, Italy

  • HUS Helsinki University Hospital

    COMPLETED

    Helsinki, 00290, Finland

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hôpital Européen Georges-Pompidou HEGP Service d'Hépato-gastro-entérologie et endoscopies digestives

    ACTIVE_NOT_RECRUITING

    Paris, 75015, France

  • Tan Tock Seng Hospital Pte Ltd,

    COMPLETED

    Singapore, 308433, Singapore

  • UCBM - Campus Bio-Medico University

    ACTIVE_NOT_RECRUITING

    Roma, 00128, Italy

  • University Medical Center Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia