Health TrialsbyHealthPanel

Endoscopic Treatment

ConditionsStenosesDyspnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Informed consent

    Other intervention

    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 check

    Other intervention

    The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.

  • Randomisation

    Other intervention

    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 questionnaire

    Behavioral

    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 questionnaire

    Behavioral

    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 questionnaire

    Behavioral

    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.

  • Spirometry

    Other intervention

    non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)

  • Chest CT scan

    Radiation

    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 Implantation

    Procedure/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 Implantation

    Procedure/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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 9 interventions
Group B: Control groupActive comparator 9 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

novatech

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: