Biological Investigation of Explanted Endobronchial Lung Valves study

Recruiting

• Conditions: Granulation tissue after endobronchial valve treatment; 10038716

• Registration Number: NL-OMON50009
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients with severe emphysema who undergo an endoscopic lung volume reduction
treatment with endobronchial valves

Written informed consent.

Exclusion Criteria

Anticoagulation which cannot be stopped

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The BIO-EXEL study is an observational study to investigate the biological<br /><br>mechanisms underlying the adverse granulation and fibrotic responses upon<br /><br>treatment with endobronchial lung valves. Therefore, the primary outcomes<br /><br>encompassment biological measurements indicating susceptibility for these<br /><br>adverse effects, including soluble factors (serum, bronchial wash biomarkers),<br /><br>genetic factors, and histological factors. Primary study parameters further<br /><br>include factors elaborating the underlying biological mechanisms of these<br /><br>adverse effects, including the presence of specific cell-types at the site of<br /><br>granulation and fibrotic responses, the presence of specific protein and<br /><br>biofilm signatures on the explanted endobronchial lung valves.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>