Actively Recruiting
Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
Led by University Medical Center Groningen · Updated on 2024-06-14
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the biological processes that affect the effectiveness and lasting benefit of bronchoscopic lung volume reduction (BLVR) treatment using endobronchial valves (EBVs) in patients with chronic obstructive pulmonary disease (COPD) or emphysema. This study aims to understand how tissue reactions like granulation and fibrosis around the implanted valves influence the treatment outcomes. The research is observational and focuses on the interaction between the lung tissue and the implanted device.
CONDITIONS
Brief 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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Duration - Initial assessment at baseline and additional assessments as needed depending on clinical status.
Participants undergo tissue and blood sampling for diagnostic purposes to assess lung valve interactions.
1 to 3 visits depending on participant group
Duration - Up to 18 months
Participants are monitored over 18 months to observe the need for rebronchoscopy and lung valve status.
Periodic visits during the 18-month follow-up period
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
D
Dirk-Jan Slebos, MD PhD
J
Jorine Hartman, PhD
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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