Biological Investigation of Explanted Endobronchial Lung Valves Study
Bio-EXCEL
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2027
June 14, 2024
June 1, 2024
6 years
December 27, 2019
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
frequency
18 months
Study Arms (3)
baseline assessment group
n=150 patiënts for baseline assessment
clinical need for reintervention group
n=20-30 patiënts for re-bronchoscopy
clinical stable controls
n=20 stable treated control patiënts
Interventions
only diagnostics will be peformed
Eligibility Criteria
Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
You may qualify if:
- Elidgible for EBV treatment
You may not qualify if:
- Anticoagulation which cannot be stopped prior to the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, Netherlands
Related Links
Biospecimen
epithial brushings blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk-Jan Slebos, MD PhD
UMC-Groningen/NL
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. D.J. Slebos MD, PhD, Principle Investigator
Study Record Dates
First Submitted
December 27, 2019
First Posted
January 2, 2020
Study Start
March 16, 2021
Primary Completion (Estimated)
March 2, 2027
Study Completion (Estimated)
March 2, 2027
Last Updated
June 14, 2024
Record last verified: 2024-06