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

NCT04848025 | Recruiting

• 1 other identifier: RC31/19/0052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

rigid bronchoscopy; 3D computer-assisted fabrication; silicon-dedicated stent

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Percentage of procedures with functional improvement

  1 seconde

• Percentage of procedures with congruence of the stent

  1 week

• Percentage of procedures without complications

  12 months

• Percentage of procedures with clinical and functional improvement

  12 months

Study Arms (1)

3D customized airway stents

EXPERIMENTAL

Device: Custom-designed tracheobronchial prostheses

Interventions

Custom-designed tracheobronchial prostheses 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

3D customized airway stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Informed consent
• Complex, proximal and symptomatic (dyspnea, cough, peak flow \< 50%, FEV1 \< 50% or post-stenotic infection) airway stenosis

You may not qualify if:

• Acute respiratory distress, mechanical ventilation
• Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
• Pregnancy

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Toulouse, 31000, France

RECRUITING

Related Publications (1)

• Chrissian AA, De Cardenas J, DuComb E, Gesthalter YB, Khosa J, Krumm IR, Channick CL. American Association of Bronchology and Interventional Pulmonology Essential Knowledge in Interventional Pulmonology Series: Selected Topics in Airway Stenting. J Bronchology Interv Pulmonol. 2026 Jan 19;33(2):e1049. doi: 10.1097/LBR.0000000000001049. eCollection 2026 Apr 1.

  PMID: 41550004 DERIVED

Study Officials

• Nicolas GUIBERT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GUIBERT, MCU-PH

CONTACT

5 67 77 81 60; guibert.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: June 17, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)