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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Disease
• Intervention / Treatment: Device: Custom-designed tracheobronchial prostheses

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas GUIBERT, MCU-PH; Phone Number: +33 5 67 77 81 60; Email: guibert.n@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • University Hospital Toulouse
    • Contact: Nicolas GUIBERT, MCU-PH; Phone Number: +33 5 67 77 81 60; Email: guibert.n@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D customized airway stents	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of procedures with functional improvement	Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))	1 seconde
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Nicolas GUIBERT, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): November 15, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: rigid bronchoscopy; 3D computer-assisted fabrication; silicon-dedicated stent
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: RC31/19/0052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No