Can 3D-printed stents solve complex airway blockages?
NCT ID NCT02889029
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates whether custom-made stents, designed using 3D computer modeling and printing, can safely treat complex airway narrowing that standard stents cannot fit. Ten adults with symptomatic, anatomically complex airway stenosis will receive a personalized stent and be followed for six months to check for complications. The goal is to see if a perfect fit can reduce serious problems like stent movement or tissue damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- custom 3D-printed airway stents
- What this could lead to
- If successful, this approach could offer a safer, personalized treatment for people with complex airway narrowing that standard stents cannot address.
- What could go wrong
- This is a very small early feasibility study with only 10 participants, so results may not apply broadly. Custom stents also carry risks like migration, infection, or tissue overgrowth.
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
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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
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10 people
The number who actually took part.
- Started
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Sep 2016
- Finished
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Nov 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 * Signature of the informed consent form * Patient with a complex upper airway stenosis . * Symptomatic stenosis ( Dyspnea \> NYHA II , cough, PEF \< 50%) * Stenosis whose complex anatomy does not allow the establishment of a currently available stent on the market: the assessment of the experts ( consensus decision between 3 bronchoscopistes of interventional endoscopy service) or after failure of one or several models. * Affiliated with a social security scheme Exclusion Criteria: * Indication of implementation of emergency aid : signs of acute respiratory distress , PEF \< 20 % predicted , SpO2 oxygen saturation \<90 % on room air * Contraindication to rigid bronchoscopy (severe coagulation disorders not correct ) * Patient under legal protection system * Pregnancy * Breastfeeding
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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.
Contacts and locations
Locations
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University Hospital Toulouse
Toulouse, CHU de Toulouse, 31059, France
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