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NCT04214587 Clinical Trial

Biological Investigation of Explanted Endobronchial Lung Valves Study

Emphysema or COPD Clinical Trial

— Bio-EXCEL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04214587
Other study ID # Bio-EXCEL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 16, 2021
Est. completion date March 2, 2027

Study information
Verified date June 2024
Source University Medical Center Groningen
Contact Dirk-Jan Slebos, MD PhD
Phone +31503616161
Email d.j.slebos@umcg.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 2, 2027
Est. primary completion date March 2, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Elidgible for EBV treatment Exclusion Criteria: - Anticoagulation which cannot be stopped prior to the procedure

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• tissue and blood sampling
only diagnostics will be peformed

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary the % of the 150 patients that will develop a need for rebronchoscopy after 18 months frequency 18 months
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