Pulmonary Emphysema
Conditions
Keywords
Emphysema, GOLD Stage III, GOLD Stage IV, AeriSeal System, Homogeneous, Heterogeneous, Upper Lobe Predominant, ULP, Chronic Obstructive Pulmonary Disease, COPD, Lung Volume Reduction Surgery, LVRS, Bronchoscopic Lung Volume Reduction, BLVR
Brief summary
* Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting; * Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.
Interventions
None listed
Sponsors
Aeris Therapeutics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced Emphysema * AeriSeal System treatment
Exclusion criteria
* have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis * have had frequent COPD exacerbations within the past year * require mechanical ventilatory support * have a pretreatment DLCO \< 20% predicted or \> 60% predicted * have a pretreatment FEV1 \< 20% predicted AND homogeneous emphysema * have giant bullae * have undergone lung transplantation, lung volume reduction surgery, or lobectomy * are intolerant of corticosteroids or antibiotics * are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Market Registry Study of the AeriSeal System | At least 4 years | -Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting |
Countries
Germany, Israel
Outcome results
None listed