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Could a 3D-Printed stent fit better and cause fewer complications?

NCT ID NCT07727824

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial compares custom-made, 3D-printed airway stents to standard ones in people with non-cancerous narrowing of the windpipe or main airways. The goal is to see if a personalized fit reduces serious complications like stent movement or tissue irritation. About 96 adults who need a silicone stent will be randomly assigned to receive either a custom or standard device and followed for a year.

What this could mean

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

Active substance
a 3D-printed, custom-fit airway stent
What this could lead to
If it works, personalized stents could lower complication rates and improve breathing for people with non-cancerous airway narrowing.
What could go wrong
This is a relatively small trial, and custom stents may not prove safer or more effective than standard ones. Risks include stent migration, infection, and tissue reactions.

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 96 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age \>18 years, * Central non-malignant symptomatic (dyspnea \> grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma), * To have access to a personal telephone for the teleconsultation scheduled in the protocol, * Informed consent signed, * Health insurance beneficiary. Exclusion Criteria: * Acute respiratory distress, * Mechanical ventilation, * Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation, * Malignant stenosis, * Pregnancy or breast-feeding, * A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example), * Patient under legal protection, - Participation in another study with an exclusion period still in progress, * Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.

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Conditions

The condition(s) this trial relates to.

Constriction, Pathologic Dyspnea tracheal stenosis

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

    6 sites. 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

  • CHRU Strasbourg

    Strasbourg, 67000, France

  • CHU Limoges

    Limoges, 87000, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Marie Lannelongue / Institut Gustave Roussy

    Le Plessis-Robinson, 92350, France

  • Institut Cœur Poumon - CHU Lille

    Lille, 59037, France

  • Larrey Hospital

    Toulouse, 31059, France

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