Post Market Registry Study of the AeriSeal System

NCT01520064 — Terminated, 25 participants, Aeris Therapeutics

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Registry	NCT01520064
Status	Terminated
Study type	Observational
Enrollment	25 (Estimated)
Sponsor	Aeris Therapeutics (Industry)
Conditions	Pulmonary Emphysema
Dates	start 2012-02-01, primary completion 2013-11-01, completion 2013-11-01, first posted 2012-01-27, last updated 2013-11-14
Locations	12 sites in Germany, Israel

-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.

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+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 40 Years to any

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)

Facility	City	Country
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Klinikum Coburg	Coburg	Germany
Klinikum Donaustauf	Donaustauf	Germany
Asklepios Fachkliniken Muenchen-Gauting	Gauting	Germany
Universitatsklinikum Halle	Halle	Germany
Asklepios Klinik Hamburg-Harburg	Hamburg	Germany
Thoraxklinik am Uniklinikum Heidelberg	Heidelberg	Germany
Sana Kliniken Luebeck	Lübeck	Germany
Klinikum Nuerberg Nord	Nuremberg	Germany
Bethanien KH Solingen	Solingen	Germany
Soroka Medical Center	Beer Sheeva	Israel
Rabin Medical Center, Beilinson Campus	Petach Tikvah	Israel

+Investigators

Janine McDermott, MS CCRP, Study director, Aeris Therapeutics