Biological Investigation of Explanted Endobronchial Lung Valves Study
Recruiting · NCT04214587 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Elidgible for EBV treatment
Exclusion criteria
- Anticoagulation which cannot be stopped prior to the procedure
Where it is running
1 location listed.
- University Medical Center Groningen - Groningen, Netherlands