NCT04214587

Biological Investigation of Explanted Endobronchial Lung Valves Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema or COPD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	tissue and blood sampling	only diagnostics will be peformed

Timeline

• Start date: 2021-03-16
• Primary completion: 2027-03-02
• Completion: 2027-03-02
• First posted: 2020-01-02
• Last updated: 2024-06-14

Locations

1 site across 1 country: Netherlands