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

Airway Disease Clinical Trial

— TATUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848025
• Other study ID #: RC31/19/0052
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Nicolas GUIBERT, MCU-PH
• Phone: 5 67 77 81 60
• Email: guibert.n[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Disease
• Constriction, Pathologic

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of procedures with clinical improvement of the dyspnea	Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12	12 months
Primary	Percentage of procedures with clinical improvement of quality of life	Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire	12 months
Secondary	Percentage of procedures with functional improvement	Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))	1 seconde
Secondary	Percentage of procedures with congruence of the stent	Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week	1 week
Secondary	Percentage of procedures without complications	Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis).	12 months
Secondary	Percentage of procedures with clinical and functional improvement	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	12 months