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Biological Investigation of Explanted Endobronchial Lung Valves Study

Biological Investigation of Explanted Endobronchial Lung Valves Study

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Phase N/A

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Overview

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

Inclusion Criteria:

  • Elidgible for EBV treatment

Exclusion Criteria:

  • Anticoagulation which cannot be stopped prior to the procedure

Study details
    Emphysema or COPD

NCT04214587

University Medical Center Groningen

26 June 2024

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