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NCT Number: NCT04848025

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31000, France

Location status: Recruiting

Location contact

Nicolas GUIBERT, MCU-PH

CONTACT

[email protected]

5 67 77 81 60 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of procedures with clinical improvement of the dyspnea

    Time frame: 12 months

    Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12

  2. Percentage of procedures with clinical improvement of quality of life

    Time frame: 12 months

    Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire

Secondary outcomes

  1. Percentage of procedures with functional improvement

    Time frame: 1 seconde

    Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))

  2. Percentage of procedures with congruence of the stent

    Time frame: 1 week

    Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week

  3. Percentage of procedures without complications

    Time frame: 12 months

    Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis).

  4. Percentage of procedures with clinical and functional improvement

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas GUIBERT, MCU-PH

CONTACT

[email protected]

5 67 77 81 60 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: TATUM

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Apr 19, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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