An observational study in COPD, sponsored by University Medical Center Groningen. Recruiting at 2 sites in Netherlands. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by University Medical Center Groningen · Observational
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 500 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Quality of treatment
Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.
Time frame: Baseline-30 days
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.
Time frame: Baseline- 5 years
Change from baseline in exercise capacity at 5 years follow up after treatment.
-Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline- 5 year
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →
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