Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
Recruiting now · Not applicable
Conditions studied: Airway Disease
In brief
Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysis). 3D customized airway stents (computer-aided conception using CT-scan data), perfectly suited to airway anatomy, should improve the tolerance and safety of airway stenting. We demonstrated in a previous pilot study, dedicated to patients with anatomically complex stenoses the safety of 3D patient-specific stents. These appealing results in highly complex situations suggest the need to evaluate these devices in more common situations. In this study we aim to test our new generation stents in all patients planned for airway stenting. After computer-assisted segmentation of airways (VGStudioMAX 3.0 software), the stenosis is virtually corrected, leading to the conception of a virtual stent (AnatomikModeling, Toulouse), allowing for the fabrication of a mold using a 3D printer. The stent is then built and sterilized (NOVATECH, Berlin) and inserted during rigid bronchoscopy. Close follow up is then conducted, including clinical evaluation after one week, three, six and 12 months; spirometry at one week, 3 months, 6 months and 12 months and chest CT-scan at one week.
Key facts
- Study ID
- NCT04848025
- Run by
- University Hospital, Toulouse
- People needed
- 30
- Starts
- 2021-06-17
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >18 years
- Informed consent
- Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis
You may not qualify if…
- Acute respiratory distress, mechanical ventilation
- Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
- Pregnancy
Where it is running
- University Hospital Toulouse — Toulouse, Toulouse, France (enrolling)
Full record on ClinicalTrials.gov
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