NCT04214587: Bio-EXCEL

Biological Investigation of Explanted Endobronchial Lung Valves Study

Recruiting now Last updated 14 June 2024

What this trial tests

trial testing tissue and blood sampling in Emphysema or COPD in 150 participants. Currently enrolling.

Timeline

16 March 2021

Primary endpoint
2 March 2027

2 March 2027

Quick facts

Lead sponsor	University Medical Center Groningen
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	150
Start date	16 March 2021
Primary completion	2 March 2027
Estimated completion	2 March 2027
Sites	1 location across Netherlands

Drugs / interventions tested

• tissue and blood sampling

Conditions studied

• Emphysema or COPD — all drugs for Emphysema or COPD →

Sponsor

University Medical Center Groningen

Who can join

Eligibility, any sex, with Emphysema or COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lung implantable devices: the issue with granulation tissue.
   Gupta A, Slebos DJ, Pouwels SD. · · 2025 · cited 1× · PMID 40673062 · DOI 10.1183/20734735.0243-2024
2. The development, validation, and <i>in vivo</i> testing of a high-precision bronchial epithelial lining fluid sampling device.
   Gupta A, Burgess JK, Slebos DJ, Pouwels SD. · · 2023 · cited 1× · PMID 37564050 · DOI 10.3389/fmed.2023.1172622