Clinical trial NCT04848025: Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
Official title: Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Disease
Keywords: rigid bronchoscopy
3D computer-assisted fabrication
silicon-dedicated stent
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Percentage of procedures with clinical improvement of the dyspnea
timeFrame: 12 months
measure: Percentage of procedures with clinical improvement of quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of procedures with functional improvement
timeFrame: 1 seconde
measure: Percentage of procedures with congruence of the stent
timeFrame: 1 week
measure: Percentage of procedures without complications
timeFrame: 12 months
measure: Percentage of procedures with clinical and functional improvement
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Nicolas GUIBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: