Post Market Registry Study of the AeriSeal System

N/ATerminatedNCT01520064

Aeris Therapeutics25 enrolled

Overview

* 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Emphysema

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (12)

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Klinikum Coburg

Coburg, Germany

Klinikum Donaustauf

Donaustauf, Germany

Outcomes

Primary Outcomes

Post Market Registry Study of the AeriSeal System

-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

Time frame: At least 4 years

Data from ClinicalTrials.gov

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