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

NCT04848025 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Not applicable

Started

2021-06-17

Last updated

2026-06-01

Condition(s) studied

Airway Disease

Investigational drug(s) / intervention(s)

Custom-designed tracheobronchial prostheses

Custom-designed tracheobronchial prostheses: Computer-assisted segmentation of airways and stent from CT data (AnatomikModeling) Fabrication of a mold and then a silicon stent by mold injection and sterilization (NOVATECH) Insertion of the stent under rigid bronchoscopy and general anesthesia

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of procedures with clinical improvement of the dyspnea — 12 months
Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12
Percentage of procedures with clinical improvement of quality of life — 12 months
Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire

Trial sites (1)

Facility	City	Region	Status
University Hospital Toulouse	Toulouse	Toulouse	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04848025 on ClinicalTrials.gov ↗ ← All trials in France