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

NCT ID: NCT04848025

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2025-12-31

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.

Conditions

Airway Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D customized airway stents

Group Type: EXPERIMENTAL

Custom-designed tracheobronchial prostheses

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas GUIBERT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, Toulouse, France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas GUIBERT, MCU-PH

Role: CONTACT

guibert.n@chu-toulouse.fr

5 67 77 81 60 ext. +33

Facility Contacts

Nicolas GUIBERT, MCU-PH

Role: primary

guibert.n@chu-toulouse.fr

5 67 77 81 60 ext. +33

Other Identifiers

RC31/19/0052

Identifier Type: -

Identifier Source: org_study_id