Post Market Registry Study of the AeriSeal System

Terminated

• Conditions: Pulmonary Emphysema

• Registration Number: NCT01520064
• Lead Sponsor: Aeris Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-27
• Study Start: 2012-02
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Soroka Medical Center; 🇮🇱 Beer Sheeva, Israel

Thoraxklinik am Uniklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Asklepios Fachkliniken Muenchen-Gauting; 🇩🇪 Gauting, Germany

Klinikum Donaustauf; 🇩🇪 Donaustauf, Germany

Universitatsklinikum Halle; 🇩🇪 Halle, Germany

Asklepios Klinik Hamburg-Harburg; 🇩🇪 Hamburg, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Sana Kliniken Luebeck; 🇩🇪 Luebeck, Germany

Klinikum Nuerberg Nord; 🇩🇪 Nurnberg, Germany

Bethanien KH Solingen; 🇩🇪 Solingen, Germany

Rabin Medical Center, Beilinson Campus; 🇮🇱 Petach Tikvah, Israel