Post Market Registry Study of the AeriSeal System
1 other identifier
observational
25
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 14, 2013
November 1, 2013
1.8 years
January 25, 2012
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At least 4 years
Eligibility Criteria
Patients must have been or will be treated with the AeriSeal System
You may qualify if:
- Advanced Emphysema
- AeriSeal System treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Klinikum Coburg
Coburg, 96450, Germany
Klinikum Donaustauf
Donaustauf, 93093, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting, 82131, Germany
Universitatsklinikum Halle
Halle, 06120, Germany
Asklepios Klinik Hamburg-Harburg
Hamburg, 21075, Germany
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, D-69126, Germany
Sana Kliniken Luebeck
Lübeck, 23560, Germany
Klinikum Nuerberg Nord
Nuremberg, 90419, Germany
Bethanien KH Solingen
Solingen, 42699, Germany
Soroka Medical Center
Beer Sheeva, 84101, Israel
Rabin Medical Center, Beilinson Campus
Petach Tikvah, 49100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janine McDermott, MS CCRP
Aeris Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
January 27, 2012
Study Start
February 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11