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Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.
Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.
Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.
Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.
Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).
Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Main study parameters/endpoints:
The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of treatment | Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves. | Baseline-30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lungfunction at 5 years follow up after treatment. | -Change from baseline in lungfunction measured by the bodybox at 5 years follow up. | Baseline- 5 years |
| Change from baseline in exercise capacity at 5 years follow up after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Klooster, PhD | Contact | +31503616161 | k.klooster@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39515624 | Derived | Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6. | |
| 32881586 | Derived | Hartman JE, Klooster K, Ten Hacken NHT, van Dijk M, Slebos DJ. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021 Jan;18(1):68-74. doi: 10.1513/AnnalsATS.202004-342OC. |
| Label | URL |
|---|---|
| Website of the bronchoscopic intervention center of the UMCG | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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-Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up. |
| Baseline- 5 years |
| Change from baseline in breathlessness at 5 years follow up after treatment. | -Change from baseline in breathlessness measured by the mMRC-scale (modified medical research council) at 5 years follow up. | Baseline- 5 years |
| Change from baseline in health status at 5 years follow up after treatment. | -Change from baseline in health status measured by the CAT (COPD Assessment test) score at 5 years follow up. | Baseline- 5 years |
| The incidence of a pneumothorax after the treatment until 5 years follow up. | The number of pneumothoraxes will be recorded between treatment and 5 years follow up. | Baseline- 5 year |
| Maastricht University Medical Center | Recruiting | Maastricht | Netherlands |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |