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

ConditionAirway Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Informed consent

Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis

Disqualifiers

Acute respiratory distress, mechanical ventilation

Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 3D customized airway stentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

Percentage of procedures with clinical improvement of quality of life

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

Time frame
12 months

Secondary outcomes

1

Percentage of procedures with functional improvement

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

Time frame
1 seconde
2

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

Time frame
1 week
3

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).

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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