Biological Investigation of Explanted Endobronchial Lung Valves Study

Last updated: June 13, 2024
Sponsor: University Medical Center Groningen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Treatment

tissue and blood sampling

Clinical Study ID

NCT04214587
Bio-EXCEL
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Elidgible for EBV treatment

Exclusion

Exclusion Criteria:

  • Anticoagulation which cannot be stopped prior to the procedure

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: tissue and blood sampling
Phase:
Study Start date:
March 16, 2021
Estimated Completion Date:
March 02, 2027

Connect with a study center

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Active - Recruiting

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