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Post Market Registry Study of the AeriSeal System

This study is currently recruiting participants.
Verified January 2012 by Aeris Therapeutics
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01520064
First received: January 25, 2012
Last updated: March 22, 2013
Last verified: January 2012
History of Changes
  Purpose
  • 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.

Condition
Pulmonary Emphysema

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Post Market Registry Study of the AeriSeal System

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Post Market Registry Study of the AeriSeal System [ Time Frame: At least 4 years ] [ Designated as safety issue: No ]
    -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


Estimated Enrollment: 25
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients must have been or will be treated with the AeriSeal System

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520064

Locations
Germany
Zentralklinik Bad Berka GmbH Recruiting
Bad Berka, Germany, 99437
Contact: Susan Wiegand     +49 0 364585-3123     studien@zentralklinik.de    
Principal Investigator: Reiner Bonnet, Dr. med            
Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: Andrea Hohn     +09561-22-7464     andrea.hoehn@klinikum-coburg.de    
Principal Investigator: Wolfgang Hohenforst-Schmidt, Dr. med.            
Klinikum Donaustauf Recruiting
Donaustauf, Germany, 93093
Contact: Gerlinde Hartl     +49 0 9403 800     Studienzentrum@klinikum-donaustauf.de    
Principal Investigator: Michael Pfeifer            
Asklepios Fachkliniken Muenchen-Gauting Recruiting
Gauting, Germany, 82131
Contact: Christa Niehaus         c.niehaus@asklepios.com    
Principal Investigator: Wolfgang Gesierich, Dr. med            
Universitatsklinikum Halle Recruiting
Halle, Germany, 06120
Contact: Susanne Behl     0345 557-3239     susanne.behl@ik-halle.de    
Principal Investigator: Bernd Schmidt, Dr. med.            
Asklepios Klinik Hamburg-Harburg Recruiting
Hamburg, Germany, 21075
Contact: Andrea Moller     +49401818865016     and.moeller@asklepios.com    
Principal Investigator: Christoph Petermann, Dr. med.            
Thoraxklinik am Uniklinikum Heidelberg Recruiting
Heidelberg, Germany, D-69126
Contact: Brigitte Rump     +49 (0)6221 3968-211     brigitte.rump@thoraxklinik-heidelberg.de    
Principal Investigator: Felix Herth, MD            
Sana Kliniken Luebeck Recruiting
Luebeck, Germany, 23560
Contact: Tahsin Balli, Dr. med.     +49 451 5851109     Tahsin.Balli@Sana.de    
Principal Investigator: Tahsin Balli, Dr. med.            
Klinikum Nuerberg Nord Recruiting
Nurnberg, Germany, 90419
Contact: Heide Wagner     +49 911 398 2674        
Principal Investigator: Manfred Wagner, Dr. med.            
Bethanien KH Solingen Not yet recruiting
Solingen, Germany, 42699
Contact: Marcel Treml, Dr.     +49 212 636001        
Principal Investigator: Winfried Randerath, Dr. med            
Israel
Soroka Medical Center Recruiting
Beer Sheeva, Israel, 84101
Contact: Yael Refaely, Dr. med.     +972 0 3 9376707     yaelrefaely@clalit.org.il    
Principal Investigator: Yael Refaely, Dr. med.            
Rabin Medical Center, Beilinson Campus Recruiting
Petach Tikvah, Israel, 49100
Contact: Mordechai Kramer, Dr. med     +972 0 3-9377221     kremerm@clalit.org.il    
Principal Investigator: Mordechai Kramer, Dr. med.            
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Study Director: Janine McDermott, MS CCRP Aeris Therapeutics
  More Information

No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01520064     History of Changes
Other Study ID Numbers: 03-C12-001PLV
Study First Received: January 25, 2012
Last Updated: March 22, 2013
Health Authority: Germany: Ethics Commission
Israel: Ministry of Health

Keywords provided by Aeris Therapeutics:
Emphysema
GOLD Stage III
GOLD Stage IV
AeriSeal System
Homogeneous
Heterogeneous
Upper Lobe Predominant
 ULP
Chronic Obstructive Pulmonary Disease
COPD
Lung Volume Reduction Surgery
LVRS
Bronchoscopic Lung Volume Reduction
BLVR

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013