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

Not Applicable

Recruiting

• Conditions: Airway Disease
• Interventions: Device: Custom-designed tracheobronchial prostheses

• Registration Number: NCT04848025
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-19
• Study Start: 2021-06-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D customized airway stents	Custom-designed tracheobronchial prostheses	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of procedures with clinical and functional improvement	12 months	Percentage of procedures with clinical (dyspnea, cough, quality of life (VQ11 questionnaire)), and functional improvement (peak flow, forced expiratory volume in one second (FEV1)) at 3 months, 6 months and 12 months
Percentage of procedures without complications	12 months	Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis).
Percentage of procedures with functional improvement	1 seconde	Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))
Percentage of procedures with congruence of the stent	1 week	Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France