Actively Recruiting

All Genders
NCT04214587

Biological Investigation of Explanted Endobronchial Lung Valves Study

Led by University Medical Center Groningen · Updated on 2024-06-14

150

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Biological Investigation of Explanted Endobronchial Lung Valves Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for EBV treatment
Not Eligible

You will not qualify if you...

  • Anticoagulation which cannot be stopped prior to the procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

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Research Team

D

Dirk-Jan Slebos, MD PhD

CONTACT

J

Jorine Hartman, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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