NCT Number: NCT07727824
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Hôpital Marie Lannelongue / Institut Gustave Roussy, Le Plessis-Robinson, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 47 months
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
Time frame: 15 months
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 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 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 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 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 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 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 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 by the peak flow from baseline to 3 and 12 months using a Student's t-test
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial
Acronym: ETNA
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.
Published trials that share one or more normalized conditions with this study.
NCT03123835
Achalasia, Body Weight
Sacramento, California, United States
View Trial DetailsNCT02179957
Constriction, Pathologic, Ischaemia
Plymouth, Devon, United Kingdom
View Trial DetailsNCT00678249
Constriction, Pathologic, Pathological Conditions, Anatomical
New York, United States
View Trial DetailsNCT07727590
Acute Cardiopulmonary Disease, Chest Pain
Seoul, South Korea
View Trial Details