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Studies lung tissue and blood around removed airway valves in COPD

Examines tissue and blood from people with emphysema or COPD after valves are removed.

Plain-language title generated from the registry record
Registry title: Biological Investigation of Explanted Endobronchial Lung Valves Study

Key facts

Where
Groningen, NetherlandsSee the site

Where in Netherlands

  • University Medical Center GroningenGroningen, NetherlandsTaking people

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Trial details

Who runs it
University Medical Center Groningen
Trial code
NCT04214587
Record updated
14 June 2024
Original description
Rationale:Read full original descriptionShow less

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

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.

Inclusion: Elidgible for EBV treatment.

Exclusion: Anticoagulation which cannot be stopped prior to the procedure.

ClinicalTrials.gov NCT04214587