Biological Investigation of Explanted Endobronchial Lung Valves study

Biological Investigation of Explanted Endobronchial Lung Valves study - BIO-EXEL study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50009

Enrollment

150

Registered

2020-05-20

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Granulation tissue after endobronchial valve treatment

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with severe emphysema who undergo an endoscopic lung volume reduction treatment with endobronchial valves Written informed consent.

Exclusion criteria

Exclusion criteria: Anticoagulation which cannot be stopped

Design outcomes

Primary

Measure	Time frame
The BIO-EXEL study is an observational study to investigate the biological mechanisms underlying the adverse granulation and fibrotic responses upon treatment with endobronchial lung valves. Therefore, the primary outcomes encompassment biological measurements indicating susceptibility for these adverse effects, including soluble factors (serum, bronchial wash biomarkers), genetic factors, and histological factors. Primary study parameters further include factors elaborating the underlying biological mechanisms of these adverse effects, including the presence of specific cell-types at the site of granulation and fibrotic responses, the presence of specific protein and biofilm signatures on the explanted endobronchial lung valves.	—

Measure

Time frame

The BIO-EXEL study is an observational study to investigate the biological mechanisms underlying the adverse granulation and fibrotic responses upon treatment with endobronchial lung valves. Therefore, the primary outcomes encompassment biological measurements indicating susceptibility for these adverse effects, including soluble factors (serum, bronchial wash biomarkers), genetic factors, and histological factors. Primary study parameters further include factors elaborating the underlying biological mechanisms of these adverse effects, including the presence of specific cell-types at the site of granulation and fibrotic responses, the presence of specific protein and biofilm signatures on the explanted endobronchial lung valves.

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Countries

Netherlands

Outcome results