About this trial
Rationale:
COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.
Objective:
The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elidgible for EBV treatment
Disqualifiers
Anticoagulation which cannot be stopped prior to the procedure
Trial population
Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
Trial design
Case-control
Prospective
Treatments tested in this trial
tissue and blood sampling
Diagnostic testonly diagnostics will be peformed
Treatment groups
Trial outcomes
Primary outcomes
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
frequency
Sponsors and contacts
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