Actively Recruiting
Biological Investigation of Explanted Endobronchial Lung Valves Study
Led by University Medical Center Groningen · Updated on 2024-06-14
150
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biological Investigation of Explanted Endobronchial Lung Valves Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for EBV treatment
You will not qualify if you...
- Anticoagulation which cannot be stopped prior to the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
D
Dirk-Jan Slebos, MD PhD
CONTACT
J
Jorine Hartman, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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