Airway DiseaseTATUMNCT04848025
Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
A study testing Custom-designed tracheobronchial prostheses in people with Airway Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Disease
- What is being tested?
- Custom-designed tracheobronchial prostheses
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2021to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Informed consent
- Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis
Who cannot join
- Acute respiratory distress, mechanical ventilation
- Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, Toulouse, 31000
Nicolas GUIBERT, MCU-PH, 5 67 77 81 60 ext. +33, guibert.n@chu-toulouse.fr
About this study
Official title: 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.
Read more
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
- Being tested
- Custom-designed tracheobronchial prostheses
- Keywords
- rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-designed tracheobronchial prosthesesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 3D customized airway stents | Experimental | Not described Receives: Device: Custom-designed tracheobronchial prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (4)
Percentage of procedures with functional improvement
Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1))
Measured: 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
Measured: 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).
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start17 Jun 2021
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GUIBERT, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848025
- Sponsor's protocol ID
- RC31/19/0052
- Acronym
- TATUM
- Status last verified
- May 2026
- First submitted
- 12 Apr 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41550004
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)
- ClinicalTrials.gov ID
- NCT04848025
- Acronym / sponsor ID
- TATUM / RC31/19/0052
- Conditions
- Airway Disease
- Keywords
- rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D customized airway stents | Experimental | Device: Custom-designed tracheobronchial prostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Informed consent
- Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis
Key exclusion criteria (3 listed)
- Acute respiratory distress, mechanical ventilation
- Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-designed tracheobronchial prosthesesComputer-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 | Device | 3D customized airway stents |
Primary outcome
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
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
4 secondary outcomes
Percentage of procedures with functional improvement
Time frame: 1 seconde
Percentage of procedures with congruence of the stent
Time frame: 1 week
Percentage of procedures without complications
Time frame: 12 months
Percentage of procedures with clinical and functional improvement
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 41550004Chrissian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas GUIBERT, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-designed tracheobronchial prostheses in people with Airway Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GUIBERT, MCU-PH (5 67 77 81 60 ext. +33, guibert.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of procedures with clinical improvement of the dyspnea (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.