Emphysema
Conditions
Keywords
Emphysema, COPD, RePneu
Brief summary
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
Interventions
DEVICELung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil
Sponsors
PneumRx, Inc.
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 35 years of age * bilateral heterogenous emphysema * Patient has stopped smoking for a minimum of 8 weeks * Read, understood and signed the Informed consent form
Exclusion criteria
* Patient has a history of recurrent significant respirator infection * Patient has an inability to walk \> 140 meters * Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc * Patient is pregnant or lactating * Patient has clinical significant bronchiectasis * Patient has had previous LVR surgery, lung transplant or lobectomy * Patient has been involved in other pulmonary drug studies within 30 days prior to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| St. George's Respiratory Questionnaire | 6 months | Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline |
Countries
France, Germany, Netherlands
Outcome results
None listed