Status:
TERMINATED
Post Market Registry Study of the AeriSeal System
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
40+ years
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; * ...
Eligibility Criteria
Inclusion
- Advanced Emphysema
- AeriSeal System treatment
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01520064
Start Date
February 1 2012
End Date
November 1 2013
Last Update
November 14 2013
Active Locations (12)
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1
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
2
Klinikum Coburg
Coburg, Germany, 96450
3
Klinikum Donaustauf
Donaustauf, Germany, 93093
4
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany, 82131