Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2016-09-30
2028-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Dirk-Jan Slebos
MD PhD
Principal Investigators
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Dirk-Jan Slebos, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMCG
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Lowie Vanfleteren, MD Phd
Role: primary
References
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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.
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.
Related Links
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Website of the bronchoscopic intervention center of the UMCG
Other Identifiers
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BREATHE-NL
Identifier Type: -
Identifier Source: org_study_id
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