A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
1 other identifier
observational
54
4 countries
8
Brief Summary
The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
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
2.8 years
April 19, 2011
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in number of Serious Adverse Events (SAE)
Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety
Weeks 48, 96, 120, 144 following treatment
Secondary Outcomes (5)
Change in Vital Signs
weeks 48, 96, 120, 144 following treatment
Change in Oxygen (O2) Use
Weeks 48, 96, 120, 144 following treatment
Change in medications
week 48, 96, 120, 144 following treatment
Change in Pulmonary Function Tests (PFT)
Weeks 48, 96, 120, 144 following treatment
Change in notable radiology results
weeks 48, 96, 120, 144 following treatment
Eligibility Criteria
All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).
You may qualify if:
- Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Otto Wagner Spital Wien
Wein, A-1140, Austria
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice, 06002 Cedex 1, France
Zentralklinik Bad Berka GmbH
Bad Berka, D-99437, Germany
Thoraxklinik Heidelberg
Heidelberg, D-69126, Germany
LungenKlinik Hemer
Hemer, D-58675, Germany
LMU Medizinische Klinik und Poliklinik Klinikum Großhadern
München, D-81377, Germany
Soroka Medical Center
Beer Sheeva, 84101, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2011
First Posted
October 10, 2011
Study Start
January 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11