Post Market Registry Study of the AeriSeal System

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01520064
First received: January 25, 2012
Last updated: November 13, 2013
Last verified: November 2013
  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:


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
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Klinikum Coburg
Coburg, Germany, 96450
Klinikum Donaustauf
Donaustauf, Germany, 93093
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany, 82131
Universitatsklinikum Halle
Halle, Germany, 06120
Asklepios Klinik Hamburg-Harburg
Hamburg, Germany, 21075
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, Germany, D-69126
Sana Kliniken Luebeck
Luebeck, Germany, 23560
Klinikum Nuerberg Nord
Nurnberg, Germany, 90419
Bethanien KH Solingen
Solingen, Germany, 42699
Israel
Soroka Medical Center
Beer Sheeva, Israel, 84101
Rabin Medical Center, Beilinson Campus
Petach Tikvah, Israel, 49100
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: November 13, 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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014