Biological Investigation of Explanted Endobronchial Lung Valves Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elidgible for EBV treatment

Disqualifiers

Anticoagulation which cannot be stopped prior to the procedure

Trial population

Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • tissue and blood sampling

    Diagnostic test

    only diagnostics will be peformed

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: baseline assessment group1 intervention
Group B: clinical need for reintervention group1 intervention
Group C: clinical stable controls1 intervention

Trial outcomes

Primary outcomes

1

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

frequency

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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