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Biological Investigation of Explanted Endobronchial Lung Valves Study

NCT04214587 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-06-14

No results posted yet for this study

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.

Conditions

  • Emphysema or COPD

Interventions

DIAGNOSTIC_TEST

tissue and blood sampling

only diagnostics will be peformed

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Dirk-Jan Slebos, MD PhD · UMC-Groningen/NL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2027-03-02
Completion
2027-03-02

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214587 on ClinicalTrials.gov