Investigation of lung valves in patients with emphysema or COPD
Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
This study is trying to understand how certain biological responses in patients with severe COPD affect the success of a treatment using lung valves to help improve their breathing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT04214587 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the biological mechanisms behind the fibrotic and granulation responses that can limit the effectiveness of bronchoscopic lung volume reduction (BLVR) treatment using endobronchial valves in patients with severe COPD. By analyzing tissue and blood samples from patients eligible for EBV treatment, the study seeks to gain insights into how these biological responses affect the longevity of the treatment. The findings could help improve future interventions and patient outcomes in managing COPD.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe COPD who are eligible for endobronchial valve treatment.
Not a fit: Patients who are on anticoagulation therapy that cannot be stopped prior to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced treatment strategies for patients with COPD, potentially improving their quality of life.
How similar studies have performed: While this study focuses on a specific biological investigation, similar approaches in understanding treatment responses in COPD have shown promise in other research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elidgible for EBV treatment Exclusion Criteria: * Anticoagulation which cannot be stopped prior to the procedure
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dirk-Jan Slebos, MD PhD — UMC-Groningen/NL
- Study coordinator: Dirk-Jan Slebos, MD PhD
- Email: d.j.slebos@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.