Endoscopic Treatment (ETNA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyspnea; Stenoses
• Intervention / Treatment: 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; Procedure: Commercially Stent Implantation

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey TOMASIK; Phone Number: +33 (0) 5 61 77 85 97; Email: tomasik.a@chu-toulouse.fr

Study Locations

• France
  • Le Plessis-Robinson, France, 92350
    • Hôpital Marie Lannelongue / Institut Gustave Roussy
    • Contact: Amir HANNA, Dr; Phone Number: +33 6 46 92 57 71; Email: a.hanna@ghpsj.fr
    • Contact: Adrian CRUTU, Dr; Phone Number: +33 1 40 94 25 78; Email: a.crutu@ghpsj.fr
  • Lille, France, 59037
    • Institut Cœur Poumon - CHU Lille
    • Contact: Clément FOURNIER, Dr; Phone Number: +33 3 20 44 44 34; Email: clement.fournier@chu-lille.fr
    • Contact: Frédéric WALLYN, Dr; Phone Number: +33 7 86 18 82 45; Email: frederic.wallyn@chu-lille.fr
  • Limoges, France, 87000
    • CHU Limoges
    • Contact: Thomas EGENOD, Dr; Phone Number: +33 5 55 05 68 92 60; Email: thomas.egenod@chu-limoges.fr
  • Strasbourg, France, 67000
    • CHRU Strasbourg
    • Contact: Michele PORZIO, Dr; Phone Number: +33 3 69 55 13 74; Email: michele.porzio@chru-strasbourg.fr
    • Contact: Cezar Aurelian MATAU, Dr; Phone Number: +33 3 69 55 07 27; Email: cezaraurelian.matau@chru-strasbourg.fr
  • Suresnes, France, 92150
    • Hôpital Foch
    • Contact: Daniela USTUROI, Dr; Phone Number: +33 6 45 91 66 63; Email: medic.pneumo@yahoo.com
  • Toulouse, France, 31059
    • Larrey Hospital
    • Contact: Nicolas GUIBERT, Pr; Phone Number: +33 (0)5 67 77 81 60; Email: guibert.n@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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; Other: Eligibility criteria check; The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.; Other: Randomisation; 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.; Behavioral: Dyspnea-12 questionnaire; 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; Behavioral: VQ11 questionnaire; 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.; Behavioral: EQ-5D-5L questionnaire; 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.; Other: Spirometry; non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1); Radiation: Chest CT scan; 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; Procedure: Experimental Stent Implantation; 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.
Active Comparator: Control group; 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; 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; Other: Eligibility criteria check; The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.; Other: Randomisation; 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.; Behavioral: Dyspnea-12 questionnaire; 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; Behavioral: VQ11 questionnaire; 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.; Behavioral: EQ-5D-5L questionnaire; 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.; Other: Spirometry; non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1); Radiation: Chest CT scan; 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; Procedure: Commercially Stent Implantation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	47 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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	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.	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.	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	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	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	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	15 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: novatech

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stent; Endoscopic Treatment; Non-malignant Airway stenoses; 3D customized stent
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constriction, Pathologic; Dyspnea; Health Care Economics and Organizations; Jurisprudence; Social Control, Formal; Patient Rights; Human Rights; Informed Consent
• Other Study ID Numbers: RC31/24/0324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No