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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04214587
Acronym
Bio-EXCEL
Enrollment
150
Registered
2020-01-02
Start date
2021-03-16
Completion date
2027-03-02
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema or COPD

Brief summary

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.

Interventions

DIAGNOSTIC_TESTtissue and blood sampling

only diagnostics will be peformed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Elidgible for EBV treatment

Exclusion criteria

* Anticoagulation which cannot be stopped prior to the procedure

Design outcomes

Primary

MeasureTime frameDescription
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months18 monthsfrequency

Countries

Netherlands

Contacts

Primary ContactDirk-Jan Slebos, MD PhD
d.j.slebos@umcg.nl+31503616161
Backup ContactJorine Hartman, PhD
j.hartman@umcg.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026