A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01449175
First received: April 19, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition
Chronic Pulmonary Obstructive Disease
Emphysema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change in number of Serious Adverse Events (SAE) [ Time Frame: Weeks 48, 96, 120, 144 following treatment ] [ Designated as safety issue: Yes ]
    Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety


Secondary Outcome Measures:
  • Change in Vital Signs [ Time Frame: weeks 48, 96, 120, 144 following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs

  • Change in Oxygen (O2) Use [ Time Frame: Weeks 48, 96, 120, 144 following treatment ] [ Designated as safety issue: No ]
    Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline.

  • Change in medications [ Time Frame: week 48, 96, 120, 144 following treatment ] [ Designated as safety issue: No ]
    Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.

  • Change in Pulmonary Function Tests (PFT) [ Time Frame: Weeks 48, 96, 120, 144 following treatment ] [ Designated as safety issue: No ]
    Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline

  • Change in notable radiology results [ Time Frame: weeks 48, 96, 120, 144 following treatment ] [ Designated as safety issue: No ]
    Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144.


Estimated Enrollment: 54
Study Start Date: January 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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 homogeneous or heterogeneous emphysema.

  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

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).

Criteria

Inclusion Criteria:

  • Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.
  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: NCT01449175

Locations
Austria
Otto Wagner Spital Wien
Wein, Austria, A-1140
France
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice, France, 06002 Cedex 1
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, D-99437
Thoraxklinik Heidelberg
Heidelberg, Germany, D-69126
LungenKlinik Hemer
Hemer, Germany, D-58675
LMU Medizinische Klinik und Poliklinik Klinikum Großhadern
München, Germany, D-81377
Israel
Soroka Medical Center
Beer Sheeva, Israel, 84101
Rabin Medical Center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Aeris Therapeutics
  More Information

No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01449175     History of Changes
Other Study ID Numbers: 03-C11-001PLV
Study First Received: April 19, 2011
Last Updated: November 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Austria: Agency for Health and Food Safety

Keywords provided by Aeris Therapeutics:
AeriSeal
treatment
device
breathing
COPD
emphysema
polymeric lung volume reduction (PLVR)
biologic lung volume reduction (BLVR)
heterogeneous
homogeneous
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

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 19, 2014