An interventional study of new 3D device in Obstructive Airway Disease, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception
Dedicated Airway Stents for Central Airway Stenoses
DASCAS
Toulouse University Hospital is the sponsor of this research.
This research will be conducted with the support of AnatomikModeling and ADERSPOT
Abstract: Central airway obstruction is currently managed with non-personalized stents, which are usually efficient but lead to severe and potentially lethal complications in 10% of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem particularly unsuited for anatomically complex stenosis.
Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically improve the tolerance and safety of such prostheses.
This first feasibility study, dedicated to patients suffering from anatomically complex stenosis will test the safety of treating patients with these new approach. It should lead to larger studies evaluating these new types of stents in larger indications.
After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the same terms as pre-existing models.
Close follow up is then conducted, including clinical evaluation after one week, three and six months; spirometry at one week and 6 months and chest CT-scan at one week.
Study design: Prospective monocentric feasibility study
Arm number or label and arm type: Only one experimental arm
Interventions:
After signature of a informed consent
Collection of clinical data (age, sex, etiology, site and mechanism of the stenosis, previous treatments dyspnea, quality of life (VQ11 questionnaire))
Chest CT-scan without contrast under continuous positive pressure
Spirometry (peak flow, FEV1)
Computer-assisted modelization of the shape of the prosthesis using 3D reconstruction of CT-scan
Machining of the shape in Ertacetal® (AnatomikModeling®)
Fabrication and sterilization of the stent in silicon (Sebbin®)
Insertion of the stent under rigid bronchoscopy and general anesthesia
Clinical follow-up at one week, 3 months and 6 months
Chest CT-scan without contrast at 1 week, spirometry at 1 week and 6 months
Number of subjects : 10 patients
Statistical analysis:
For the primary outcome, percentages of procedures conducted without complication at 1 week, 3 months, and 6 months and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.
For secondary outcomes:
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 10 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
dedicated tailored stents wrought by 3D computer-assisted conception
Device: new 3D device
dedicated tailored stents wrought by 3D computer-assisted conception
Change of percentage of procedures conducted without complications at 1 week , 3 months and 6 months
percentages of procedures conducted without complication at 1 week, 3 months and 6 month and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.
Time frame: Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse