BridgeMD
Compares treatment options for COPD
Official title 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
ClinicalTrials.gov ID: NCT06181357
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 80
You may be able to join if
- 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 ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
- Smoking quit for 3 months
You likely can't join if
- 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...
- Pulmonary tomoscintigraphy:
See the full eligibility 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
- 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...
- Pulmonary tomoscintigraphy:
- Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score
- Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10%
- Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 \ 55 mmHg)
- Echocardiography:
- Left Ventricular Ejection Function \< 45%
- Systolic pulmonary arterial pressure \> 45 mmHg
- History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction
- History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction
- History of endoscopic volume reduction
- Oral corticosteroid therapy \> 20 mg/day within the 4 weeks preceding inclusion
- Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin
- Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago
- Pregnant or breastfeeding women
- Nickel allergy
- Patient under guardianship, curatorship or under judicial protection
- Participation in another treatment clinical research
- Any other condition which, in the opinion of the investigator, could interfere with the objective of the study or would cause the subject's participation in the study to be suboptimal, in particular (non-exhaustive...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Brest, France
- Bron, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Marseille, France
- Nice, France
- Paris, France
- Rouen, France
- Saint-Etienne, France
- Strasbourg, France
- Suresnes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Brest, France; Bron, France; Dijon, France; Grenoble, France; Lille, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.