Treatment of airway blockages with customized 3D stents
Official title: Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)
Run by University Hospital, Toulouse · NCT04848025 · Data updated 2026-11-12
This study is testing whether specially designed 3D stents can help people with airway blockages breathe better and feel more comfortable than regular stents.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, Toulouse) |
| Status | Recruiting |
| Started | June 17, 2021 |
| Main results expected | December 30, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT04848025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with complex, symptomatic airway stenosis causing significant respiratory issues.
✕Probably not a fit
Patients experiencing acute respiratory distress or those who cannot undergo rigid bronchoscopy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of computer-assisted, customized 3D stents for treating central airway stenoses. By utilizing CT-scan data, the stents are designed to fit the unique anatomy of each patient's airway, potentially improving safety and tolerance compared to traditional stenting methods. The study aims to assess these new generation stents in a broader patient population, building on promising results from a previous pilot study focused on complex cases. Participants will undergo rigid bronchoscopy for stent placement, with the stents being fabricated using advanced 3D printing technology.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications associated with airway stenting and improve patient outcomes.
How similar studies have gone: Previous studies have shown promising results with similar 3D stent approaches, indicating potential for success in this broader evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Informed consent * Complex, proximal and symptomatic (dyspnea, cough, peak flow \< 50%, FEV1 \< 50% or post-stenotic infection) airway stenosis Exclusion Criteria: * Acute respiratory distress, mechanical ventilation * Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders) * Pregnancy
Where it's running
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University Hospital Toulouse
Toulouse, Toulouse, France Recruiting
Study contacts
- Principal investigator: Nicolas GUIBERT, MD — University Hospital, Toulouse
- Study coordinator: Nicolas GUIBERT, MCU-PH
- Email: guibert.n@chu-toulouse.fr
- Phone: 5 67 77 81 60
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.