Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Redu… (NCT06181357) | Clinical Trial Compass
RecruitingNot Applicable
Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
France244 participantsStarted 2024-05-06
Plain-language summary
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.
Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.
If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.
A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.
These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient able to give informed consent and participate in the study
* Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
* Emphysema (homogeneous or heterogeneous) on a recent CT scan (\< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
* Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
* Smoking quit for 3 months
* Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire)
* Post-bronchodilator FEV between 15 and 50% theoretical
* Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical
* Distance traveled during the TM6M ≥ 100m
* Member of or beneficiary of a social security scheme
Exclusion Criteria:
* Asthma considered as main diagnosis
* Recurrent exacerbations: (\>3 over the last year or 2 requiring hospitalization)
* Myocardial infarction or stroke in the 6 months prior to inclusion
* Symptoms of heart failure in the 6 months prior to inclusion
* Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi
* Pulmonary tomoscintigraphy:
* Patients for whom the least perfused lobe is not the one with the highest emphyse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.