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NCT04214587Recruiting

Biological Investigation of Explanted Endobronchial Lung Valves Study

Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions

Source: ClinicalTrials.gov · Last updated 14 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
27 Dec 2019
Start date
16 Mar 2021
Primary completion date
2 Mar 2027
Lead sponsor
University Medical Center Groningen
Diseases
COPD
NCT number
NCT04214587

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 16 Mar 2021 to the primary completion date, 2 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Anticoagulation which cannot be stopped prior to the procedure

Who the study is looking for

  • Elidgible for EBV treatment

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Center Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.