Treatment of Central Airway Narrowing Using Customized 3D Airway Stents Made by Computer Modeling
Led by University Hospital, Toulouse · Updated on 2026-06-01
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating new 3D customized airway stents designed with computer-aided modeling using CT scan data to treat central airway obstruction. These stents are tailored to fit the airway anatomy perfectly and aim to improve the safety and tolerance of airway stenting compared to standard stents, which can cause serious complications such as stent migration, obstructive granuloma, perforation, and bleeding. The study builds on previous pilot research that showed safety in complex airway stenoses and now includes a broader patient group scheduled for airway stenting.
The study uses computer-assisted segmentation of the airways to virtually correct the stenosis and design a personalized stent mold using 3D printing technology. The final silicone stent is then sterilized and inserted during rigid bronchoscopy under general anesthesia. Patients receive this new generation of airway stents specifically created for their anatomy, aiming to improve outcomes and reduce complications.
Participants are closely followed with clinical evaluations at one week, three, six, and twelve months after stent insertion. Lung function tests spirometry occur at one week, three, six, and twelve months, and chest CT scans are performed one week post-procedure. Researchers measure improvements in breathing difficulty dyspnea, quality of life, lung function, stent fit, and complication rates up to one year after treatment. This thorough monitoring helps assess the stents performance and safety over time.
CONDITIONS
Brief Title
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
Research Team
N
Nicolas GUIBERT, MCU-PH
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Have complex, proximal, and symptomatic airway narrowing with symptoms like difficulty breathing, cough, peak flow below 50%, FEV1 below 50%, or infection after the narrowing
You will not qualify if you...
Having acute respiratory distress or being on mechanical ventilation
Having severe and irreversible blood clotting disorders preventing rigid bronchoscopy
Being pregnant
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure with follow-up as per protocol
Participants receive custom-designed tracheobronchial prostheses, which are inserted under rigid bronchoscopy and general anesthesia after computer-assisted design and fabrication.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months
Participants are monitored for clinical improvement, stent congruence, functional outcomes, and complications over 12 months after stent placement.
Multiple follow-up visits over 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
American Association of Bronchology and Interventional Pulmonology Essential Knowledge in Interventional Pulmonology Series: Selected Topics in Airway Stenting.
Ara A Chrissian, Jose De Cardenas, Emily DuComb...