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Post Market Registry Study of the AeriSeal System

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

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 ]
    -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)

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must have been or will be treated with the AeriSeal System

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
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Please refer to this study by its identifier: NCT01520064

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
Soroka Medical Center
Beer Sheeva, Israel, 84101
Rabin Medical Center, Beilinson Campus
Petach Tikvah, Israel, 49100
Sponsors and Collaborators
Aeris Therapeutics
Study Director: Janine McDermott, MS CCRP Aeris Therapeutics
  More Information

Responsible Party: Aeris Therapeutics Identifier: NCT01520064     History of Changes
Other Study ID Numbers: 03-C12-001PLV
Study First Received: January 25, 2012
Last Updated: November 13, 2013

Keywords provided by Aeris Therapeutics:
AeriSeal System
Upper Lobe Predominant
Chronic Obstructive Pulmonary Disease
Lung Volume Reduction Surgery
Bronchoscopic Lung Volume Reduction

Additional relevant MeSH terms:
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases processed this record on May 25, 2017