Biological Investigation of Explanted Endobronchial Lung Valves Study

Recruiting

• Conditions: Emphysema or COPD
• Interventions: Diagnostic Test: tissue and blood sampling

• Registration Number: NCT04214587
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2021-03-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2027-03-02
• Study Completion: 2027-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Elidgible for EBV treatment

Exclusion Criteria

• Anticoagulation which cannot be stopped prior to the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
baseline assessment group	tissue and blood sampling	n=150 patiënts for baseline assessment
clinical stable controls	tissue and blood sampling	n=20 stable treated control patiënts
clinical need for reintervention group	tissue and blood sampling	n=20-30 patiënts for re-bronchoscopy

Primary Outcome Measures

Name	Time	Method
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months	18 months	frequency

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands