Biological Investigation of Explanted Endobronchial Lung Valves Study
NCT ID: NCT04214587
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-03-16
2027-03-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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baseline assessment group
n=150 patiënts for baseline assessment
tissue and blood sampling
only diagnostics will be peformed
clinical need for reintervention group
n=20-30 patiënts for re-bronchoscopy
tissue and blood sampling
only diagnostics will be peformed
clinical stable controls
n=20 stable treated control patiënts
tissue and blood sampling
only diagnostics will be peformed
Interventions
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tissue and blood sampling
only diagnostics will be peformed
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Dirk-Jan Slebos
Prof. dr. D.J. Slebos MD, PhD, Principle Investigator
Principal Investigators
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Dirk-Jan Slebos, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMC-Groningen/NL
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Dirk-Jan Slebos, PhD
Role: primary
Related Links
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The UMC-Groningen/NL Bronchoscopic Intervention Center website
Other Identifiers
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Bio-EXCEL
Identifier Type: -
Identifier Source: org_study_id
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