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

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:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

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
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449175

Locations

Austria
Otto Wagner Spital Wien	Recruiting
Wein, Austria, A-1140
Contact: Sherwin Asadi +43 664 4385355 mail@sherwinasadi.com
Principal Investigator: Arschang Valipour, MD
France
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice	Recruiting
Nice, France, 06002 Cedex 1
Contact: Jennifer Griffonnet +33 4 92 03 82 81 Griffonnet.j@chu-nice.fr
Principal Investigator: Charles Marquette, MD
Germany
Zentralklinik Bad Berka GmbH	Not yet recruiting
Bad Berka, Germany, D-99437
Contact: Yvonne Lautenschlaeger +49 (0)36458 53122 y.lautenschlaeger.aed@zentralklinik-bad-berka.de
Principal Investigator: Reiner Bonnet, MD
Thoraxklinik Heidelberg	Recruiting
Heidelberg, Germany, D-69126
Contact: Brigitte Rump +49 (0)6221 3968-211 brigitte.rump@thoraxklinik-heidelberg.de
Principal Investigator: Felix Herth, MD
LungenKlinik Hemer	Not yet recruiting
Hemer, Germany, D-58675
Contact: Melanie Dombek +49 (0)237-29082167 Melanie.dombek@lkhemer.de
Principal Investigator: Franz Stanzel, MD
LMU Medizinische Klinik und Poliklinik Klinikum Großhadern	Not yet recruiting
München, Germany, D-81377
Contact: Mirjam Landmesser +49 (0)89 7095 3071 mirjam.landmesser@med.uni-muenchen.de
Principal Investigator: Claus Neurohr, MD
Israel
Soroka Medical Center	Not yet recruiting
Beer Sheeva, Israel, 84101
Contact: Yulia Fishilevich 972 8 6400962 zalkiny@bgu.ac.il
Principal Investigator: Yael Rafaely, MD
Rabin Medical Center, Beilinson Hospital	Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Liora Yehoshua 972 3 9377214 lioray@clalit.org.il
Principal Investigator: Mordechai Kremer, MD

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:	October 7, 2011
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
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013