Could a 3D-Printed stent fit better and cause fewer complications?
NCT ID NCT07727824
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dyspnea are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
6 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Three oxygen sensors, one question: can site differences flag the sickest breathless patients?
- Can a handheld breathing device and phone app help COPD patients breathe easier?
- Can a video call save a Child's life? emergency triage goes visual
- A simple breath: could guided breathing calm heart failure symptoms?
- Can a touch on the hands ease Asthma's breathlessness and sleeplessness?
- Can a Hand-Based therapy ease COPD's toughest symptoms?