Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous Emphysema

Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous Emphysema - LVR-coil study CLN0012

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35800

Enrollment

Registered

2011-10-24

Start date

2011-11-30

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

COPD Emphysema

Interventions

Nitinol Lung Volume Ruduction Coils will be placed in both lungs during two bronchoscopic procedures, with an interval of 2 months, aiming to induce a volume reduction and therefore aiming to improv

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Homogeneous emphysema on CT-thorax Post-bronchodilator FEV1 120% predicted Residual Volume > 225% predicted mMRC dyspnea score >2 Stopped smoking > 6 months

Exclusion criteria

Exclusion criteria: History of recurrent respiratory infections Cardiovasculair pathology Inability to walk > 140 meters in 6 minutes Giant bullae (> 1/3 lung volume) Patient is taking > 20 mg prednisone (or similar steroid) daily Patient has evidence of other disease that may compromise survival (such as lung cancer, renal failure etc)

Design outcomes

Primary

Measure	Time frame
Differences between baseline visit and follow-up visit Six minutes walk test (m) .	—

Secondary

Measure	Time frame
Differences between baseline visit and 6 month follow-up visit PFT measurements and quality of Life parameters (questionnaires).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)