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RECRUITING
NCT04214587

Biological Investigation of Explanted Endobronchial Lung Valves Study

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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.

Official title: Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2021-03-16

Completion Date

2027-03-02

Last Updated

2024-06-14

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

tissue and blood sampling

only diagnostics will be peformed

Locations (1)

University Medical Center Groningen

Groningen, Netherlands