Post Market Registry Study of the AeriSeal System

NCT ID: NCT01520064

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

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

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* 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.

Detailed Description

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Conditions

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Pulmonary Emphysema

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
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

Principal Investigators

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Janine McDermott, MS CCRP

Role: STUDY_DIRECTOR

Aeris Therapeutics

Locations

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Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status

Klinikum Coburg

Coburg, , Germany

Site Status

Klinikum Donaustauf

Donaustauf, , Germany

Site Status

Asklepios Fachkliniken Muenchen-Gauting

Gauting, , Germany

Site Status

Universitatsklinikum Halle

Halle, , Germany

Site Status

Asklepios Klinik Hamburg-Harburg

Hamburg, , Germany

Site Status

Thoraxklinik am Uniklinikum Heidelberg

Heidelberg, , Germany

Site Status

Sana Kliniken Luebeck

Lübeck, , Germany

Site Status

Klinikum Nuerberg Nord

Nuremberg, , Germany

Site Status

Bethanien KH Solingen

Solingen, , Germany

Site Status

Soroka Medical Center

Beer Sheeva, , Israel

Site Status

Rabin Medical Center, Beilinson Campus

Petach Tikvah, , Israel

Site Status

Countries

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Germany Israel

Other Identifiers

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03-C12-001PLV

Identifier Type: -

Identifier Source: org_study_id