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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| baseline assessment group | n=150 patiënts for baseline assessment |
| |
| clinical need for reintervention group | n=20-30 patiënts for re-bronchoscopy |
| |
| clinical stable controls | n=20 stable treated control patiënts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tissue and blood sampling | Diagnostic Test | only diagnostics will be peformed |
|
| Measure | Description | Time Frame |
|---|---|---|
| the % of the 150 patients that will develop a need for rebronchoscopy after 18 months | frequency | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dirk-Jan Slebos, MD PhD | Contact | +31503616161 | d.j.slebos@umcg.nl | |
| Jorine Hartman, PhD | Contact | j.hartman@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD PhD | UMC-Groningen/NL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | Netherlands |
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| Label | URL |
|---|---|
| The UMC-Groningen/NL Bronchoscopic Intervention Center website | View source |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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epithial brushings blood
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D013048 | Specimen Handling |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |