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NCT04214587 | RECRUITING | Emphysema or COPD


Biological Investigation of Explanted Endobronchial Lung Valves Study
Sponsor:

University Medical Center Groningen

Information provided by (Responsible Party):

Dirk-Jan Slebos

Brief 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.

Condition or disease

Emphysema or COPD

Intervention/treatment

tissue and blood sampling

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
Actual Study Start Date : 2021-03-16
Estimated Primary Completion Date : 2027-03-02
Estimated Study Completion Date : 2027-03-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Elidgible for EBV treatment
Exclusion Criteria
  • * Anticoagulation which cannot be stopped prior to the procedure

Biological Investigation of Explanted Endobronchial Lung Valves Study

Location Details

NCT04214587


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How to Participate

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Locations


RECRUITING

Netherlands,

University Medical Center Groningen

Groningen, Netherlands,

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