An observational study in Emphysema or COPD, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by University Medical Center Groningen · Observational
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.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 150 is above the median of 131 across 111 observational studies indexed under Emphysema.
Browse Emphysema studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction 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:
n=150 patiënts for baseline assessment
Diagnostic Test: tissue and blood sampling
n=20-30 patiënts for re-bronchoscopy
Diagnostic Test: tissue and blood sampling
n=20 stable treated control patiënts
Diagnostic Test: tissue and blood sampling
only diagnostics will be peformed
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
frequency
Time frame: 18 months
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen →