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

NCT ID: NCT01449175

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pulmonary Obstructive Disease Emphysema

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aeris Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Otto Wagner Spital Wien

Wein, , Austria

Site Status

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status

Thoraxklinik Heidelberg

Heidelberg, , Germany

Site Status

LungenKlinik Hemer

Hemer, , Germany

Site Status

LMU Medizinische Klinik und Poliklinik Klinikum Großhadern

München, , Germany

Site Status

Soroka Medical Center

Beer Sheeva, , Israel

Site Status

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Site Status

Countries

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Austria France Germany Israel

Other Identifiers

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03-C11-001PLV

Identifier Type: -

Identifier Source: org_study_id