CompletedInterventionalPhase 1Phase 2Updated Jun 26, 2013
Post Market Registry Study of the AeriSeal System | NCT01520064 | Trialant
TerminatedObservationalUpdated Nov 14, 2013
Post Market Registry Study of the AeriSeal System
Post Market Registry Study of the AeriSeal System
ClinicalTrials.gov ID
NCT01520064
Lead Sponsor
Aeris TherapeuticsINDUSTRY
Overall Status
Terminated
Study Type
Observational
Enrollment
25Estimated
Last Update Posted
Nov 14, 2013Estimated
Start Date
Feb 2012
Primary Completion Date
Nov 2013Actual
Completion Date
Nov 2013Actual
Official Title
Post Market Registry Study of the AeriSeal System
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.
Pulmonary Emphysema
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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