StenosesETNANCT07727824
Endoscopic Treatment
A study testing Informed consent, Eligibility criteria check and Randomisation in people with Stenoses and Dyspnea, run by University Hospital, Toulouse at 6 sites in France.
Trial summary
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Informed consent, Eligibility criteria check and Randomisation
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2027to Jan 2031
- 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,
- Central non-malignant symptomatic (dyspnea > grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
- To have access to a personal telephone for the teleconsultation scheduled in the protocol,
- Informed consent signed,
- Health insurance beneficiary.
Who cannot join
- Acute respiratory distress,
- Mechanical ventilation,
- Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
- Malignant stenosis,
- Pregnancy or breast-feeding,
- A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example),
- Patient under legal protection, - Participation in another study with an exclusion period still in progress,
- Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
Hôpital Marie Lannelongue / Institut Gustave Roussy
Le Plessis-Robinson, 92350
Amir HANNA, Dr, 6 46 92 57 71 ext. +33, a.hanna@ghpsj.fr
Adrian CRUTU, Dr, 1 40 94 25 78 ext. +33, a.crutu@ghpsj.fr
Institut Cœur Poumon - CHU Lille
Lille, 59037
Clément FOURNIER, Dr, 3 20 44 44 34 ext. +33, clement.fournier@chu-lille.fr
Frédéric WALLYN, Dr, 7 86 18 82 45 ext. +33, frederic.wallyn@chu-lille.fr
CHU Limoges
Limoges, 87000
Thomas EGENOD, Dr, 5 55 05 68 92 60 ext. +33, thomas.egenod@chu-limoges.fr
CHRU Strasbourg
Strasbourg, 67000
Michele PORZIO, Dr, 3 69 55 13 74 ext. +33, michele.porzio@chru-strasbourg.fr
Cezar Aurelian MATAU, Dr, 3 69 55 07 27 ext. +33, cezaraurelian.matau@chru-strasbourg.fr
Hôpital Foch
Suresnes, 92150
Daniela USTUROI, Dr, 6 45 91 66 63 ext. +33, medic.pneumo@yahoo.com
Larrey Hospital
Toulouse, 31059
Nicolas GUIBERT, Pr, +33 (0)5 67 77 81 60, guibert.n@chu-toulouse.fr
About this study
Official title: Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
- Being tested
- Informed consent, Eligibility criteria check, Randomisation, Dyspnea-12 questionnaire, VQ11 questionnaire
- Keywords
- Non-malignant Airway stenoses, Endoscopic Treatment, 3D customized stent, stent
- Medical subject headings
- Constriction, Pathologic, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed consentOther
During the pre-inclusion/inclusion visit, the investigator informs the participant and answers all questions regarding the purpose, nature of the constraints, foreseeable risks and the expected benefits of the clinical investigation. The investigating physician then provides the participant with a copy of the information note and informed consent form. After this information session, the participant is granted a reflection period. If the participant agrees to participate
Eligibility criteria checkOther
The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.
RandomisationOther
When an investigator wishes to perform the randomisation after checking the eligibility criteria and consent of the participant, he/she will connect to the dedicated Clinsight Website.
Dyspnea-12 questionnaireBehavioural
The DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely
VQ11 questionnaireBehavioural
The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely.
EQ-5D-5L questionnaireBehavioural
This questionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function.
SpirometryOther
non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)
Chest CT scanRadiation
High resolution chest CT scan without injection of contrast medium. The scanner required for the manufacture of the prosthesis must be a high-resolution CT scanner, the recommendations for which are specified in the order file for a 3D stent
Commercially Stent ImplantationProcedure or surgery
During the commercially stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.
Experimental Stent ImplantationProcedure or surgery
During the experimental stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | After computer-assisted segmentation of the airways and correction of the stenosis VGStudioMAX 3.0) using the CT data, a virtual stent (AnatomikModeling) and mold are designed. The latter is then 3D printed and used for the stent fabrication in silicone (NOVATECH) which is inserted through a rigid bronchoscope. Receives: Other: Informed consent; Other: Eligibility criteria check; Other: Randomisation; Behavioral: Dyspnea-12 questionnaire; Behavioral: VQ11 questionnaire; Behavioral: EQ-5D-5L questionnaire; Other: Spirometry; Radiation: Chest CT scan; Procedure: Experimental Stent Implantation |
| Control group | Active comparator | Commercially available stents (NOVATECH) are inserted following the exact same modalities (general anesthesia) and tools (rigid bronchoscope, rigid forceps) than for 3D stents. Receives: Other: Informed consent; Other: Eligibility criteria check; Other: Randomisation; Behavioral: Dyspnea-12 questionnaire; Behavioral: VQ11 questionnaire; Behavioral: EQ-5D-5L questionnaire; Other: Spirometry; Radiation: Chest CT scan; Procedure: Commercially Stent Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
Measured: 47 months
Secondary outcomes (9)
Rate (percent) of all adverse events
Rate (percent) of all adverse events at 3, 6 and 12 months, specifying the causal relationship with the procedure and the MD (certain, probable, possible, not-related) and the intensity (grade).
Measured: 15 months
Evolution in dyspnea
Evolution in dyspnea by mMRC from baseline to 3, 6 and 12 months of follow-up using a Student's t-test.
The mMRC (MODIFIED MEDICAL RESEARCH COUNCIL) is a scale for assessing dyspnea. There are five stages of dyspnea, numbered from 0 to 4, with 4 being the stage where shortness of breath is most severe.
Measured: 15 months
Evolution in dyspnea
Evolution in dyspnea by dyspnea 12 from baseline to 3, 6 and 12 months of follow-up using a Student's t-test The DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely
Measured: 15 months
Evolution of quality of life
Evolution of quality of life by VQ11 questionnaire from baseline to 3, 6 and 12 months of follow-up using a Student's t-test. The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely.
Measured: 15 months
Evolution of quality of life
Evolution of quality of life by EQ-5D-L questionnaire from baseline to 3, 6 and 12 months of follow-up using a Student's t-test.
The EQ-5D-5Lquestionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function.
Measured: 15 months
Change in pulmonary function tests
Change in pulmonary function tests by pulmonary function tests from baseline to 3 and 12 months using a Student's t-test
Measured: 15 months
Change in pulmonary function tests
Change in pulmonary function tests by FEV1 from baseline to 3 and 12 months using a Student's t-test.
FEV1 is a non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second
Measured: 15 months
Change in pulmonary function tests
Change in pulmonary function tests by Forced Vital Capacity from baseline to 3 and 12 months using a Student's t-test
Measured: 15 months
Change in pulmonary function tests
Change in pulmonary function tests by the peak flow from baseline to 3 and 12 months using a Student's t-test
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- novatech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727824
- Sponsor's protocol ID
- RC31/24/0324
- Acronym
- ETNA
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07727824
- Acronym / sponsor ID
- ETNA / RC31/24/0324
- Keywords
- Non-malignant Airway stenoses, Endoscopic Treatment, 3D customized stent, stent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- novatech
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 27 Jul 2026 (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.
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Informed consent, Other: Eligibility criteria check, Other: Randomisation, Behavioral: Dyspnea-12 questionnaire, Behavioral: VQ11 questionnaire, Behavioral: EQ-5D-5L questionnaire, Other: Spirometry, Radiation: Chest CT scan, Procedure: Experimental Stent ImplantationAfter computer-assisted segmentation of the airways and correction of the stenosis VGStudioMAX 3.0) using the CT data, a virtual stent (AnatomikModeling) and mold are designed. The latter is then 3D printed and used for the stent fabrication in silicone (NOVATECH) which is inserted through a rigid bronchoscope. |
| Control group | Active comparator | Other: Informed consent, Other: Eligibility criteria check, Other: Randomisation, Behavioral: Dyspnea-12 questionnaire, Behavioral: VQ11 questionnaire, Behavioral: EQ-5D-5L questionnaire, Other: Spirometry, Radiation: Chest CT scan, Procedure: Commercially Stent ImplantationCommercially available stents (NOVATECH) are inserted following the exact same modalities (general anesthesia) and tools (rigid bronchoscope, rigid forceps) than for 3D stents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years,
- Central non-malignant symptomatic (dyspnea > grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
- To have access to a personal telephone for the teleconsultation scheduled in the protocol,
- Informed consent signed,
- Health insurance beneficiary.
Key exclusion criteria (8 listed)
- Acute respiratory distress,
- Mechanical ventilation,
- Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
- Malignant stenosis,
- Pregnancy or breast-feeding,
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 |
|---|---|---|
| Informed consentDuring the pre-inclusion/inclusion visit, the investigator informs the participant and answers all questions regarding the purpose, nature of the constraints, foreseeable risks and the expected benefits of the clinical investigation. The investigating physician then provides the participant with a copy of the information note and informed consent form. After this information session, the participant is granted a reflection period. If the participant agrees to participate | Other | Control group, Experimental group |
| Eligibility criteria checkThe investigator also specifies the participant's rights in the context of research and checks the eligibility criteria. | Other | Control group, Experimental group |
| RandomisationWhen an investigator wishes to perform the randomisation after checking the eligibility criteria and consent of the participant, he/she will connect to the dedicated Clinsight Website. | Other | Control group, Experimental group |
| Dyspnea-12 questionnaireThe DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely | Behavioural | Control group, Experimental group |
| VQ11 questionnaireThe VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely. | Behavioural | Control group, Experimental group |
| EQ-5D-5L questionnaireThis questionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function. | Behavioural | Control group, Experimental group |
| Spirometrynon-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1) | Other | Control group, Experimental group |
| Chest CT scanHigh resolution chest CT scan without injection of contrast medium. The scanner required for the manufacture of the prosthesis must be a high-resolution CT scanner, the recommendations for which are specified in the order file for a 3D stent | Radiation | Control group, Experimental group |
| Commercially Stent ImplantationDuring the commercially stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse. | Procedure or surgery | Control group |
| Experimental Stent ImplantationDuring the experimental stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse. | Procedure or surgery | Experimental group |
Primary outcome
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
Time frame: 47 months
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
9 secondary outcomes
Rate (percent) of all adverse events
Time frame: 15 months
Evolution in dyspnea
Time frame: 15 months
Evolution in dyspnea
Time frame: 15 months
Evolution of quality of life
Time frame: 15 months
Evolution of quality of life
Time frame: 15 months
Change in pulmonary function tests
Time frame: 15 months
Change in pulmonary function tests
Time frame: 15 months
Change in pulmonary function tests
Time frame: 15 months
Change in pulmonary function tests
Time frame: 15 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 27 Jul 2026.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed consent, Eligibility criteria check and Randomisation in people with Stenoses and Dyspnea, run by University Hospital, Toulouse at 6 sites 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Audrey TOMASIK (+33 (0) 5 61 77 85 97, tomasik.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s) (time frame: 47 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.