TerminatedNot Applicable

Post Market Registry Study of the AeriSeal System

Germany25 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Post Market Registry Study of the AeriSeal System

Timeframe: At least 4 years

Trial details

NCT IDNCT01520064

SponsorAeris Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Pulmonary Emphysema trials