An interventional study of Informed consent and Eligibility criteria check in Stenoses and Dyspnea, sponsored by University Hospital, Toulouse. Not yet recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 96 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Commercially available stents (NOVATECH) are inserted following the exact same modalities (general anesthesia) and tools (rigid bronchoscope, rigid forceps) than for 3D stents.
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
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
The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.
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.
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
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.
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.
non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)
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
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.
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.
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)
Time frame: 47 months
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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 15 months
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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