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

Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Emphysema. - LVR-Coil Safety Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35583

Enrollment

Registered

2009-03-16

Start date

2009-04-14

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 3 months because of safety follow-up, aiming to induce a volume reduction an

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Emphysema on HRCT-thorax Post-bronchodilator FEV1 100% predicted mMRC dyspnea score >2 Stopped smoking > 8 weeks

Exclusion criteria

Exclusion criteria: History of recurrent respiratory infections and/or bronchiectasis 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
Safety Improvement in St. George's Respiratory Questionnaire (SGRQ) total score	—

Secondary

Measure	Time frame
Differences between baseline visit and 3 month follow-up visit FEV1 (L) RV/TLC (%) Residual Volume (L) Six minutes walk test (m) modified Medical Research Counsil Dyspnea Scale (mMRC) Oxygen use	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)