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NCT Number: NCT04214587

Biological Investigation of Explanted Endobronchial Lung Valves Study

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Netherlands

Location status: Recruiting

Location contact

Dirk-Jan Slebos, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elidgible for EBV treatment

Exclusion criteria

  • Anticoagulation which cannot be stopped prior to the procedure

Treatment and study plan

tissue and blood sampling

Diagnostic Test

only diagnostics will be peformed

Primary outcomes

  1. the % of the 150 patients that will develop a need for rebronchoscopy after 18 months

    Time frame: 18 months

    frequency

Study contacts

Contact information is provided by the study sponsor or research team.

Dirk-Jan Slebos, MD PhD

CONTACT

[email protected]

+31503616161

Jorine Hartman, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: Bio-EXCEL

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2020
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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