Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD

Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD - STELVIO Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39131

Enrollment

Registered

2011-06-10

Start date

2011-06-21

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

COPD Emphysema

Interventions

Placement of oneway-valves during a bronchoscopy. (Bronchoscopic lungvolume reduction)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Heterogeneous emphysema on CT scan Complete fissures on CT scan Signed Informed Consen

Exclusion criteria

Exclusion criteria: Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2

Design outcomes

Primary

Measure	Time frame
Clinical Evaluation: a clinical significant improvement of FVC, FEV1 and 6 minutes walk test. Economic Evaluation: total costs of the bronchoscopic lung volume reduction compared to usual care and (historical) costs of LVRS.	—

Secondary

Measure	Time frame
Quality of life (measured by SGRQ, CCQ) Target lobar volume change on a full inspiratory thin slice CT scan	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)