Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3D Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)

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 stent's performance and safety over time.

Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM