Biological Investigation of Explanted Endobronchial Lung Valves Study (Bio-EXCEL)

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Emphysema or COPD

Treatments: Diagnostic Test: tissue and blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04214587

Bio-EXCEL

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elidgible for EBV treatment

Exclusion criteria

• Anticoagulation which cannot be stopped prior to the procedure

Trial design

150 participants in 3 patient groups

baseline assessment group

Description:

n=150 patiënts for baseline assessment

Treatment:

Diagnostic Test: tissue and blood sampling

clinical need for reintervention group

Description:

n=20-30 patiënts for re-bronchoscopy

Treatment:

Diagnostic Test: tissue and blood sampling

clinical stable controls

Description:

n=20 stable treated control patiënts

Treatment:

Diagnostic Test: tissue and blood sampling