A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

Detailed Description

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Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Conditions

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Pulmonary Emphysema Chronic Obstructive Pulmonary Disease(COPD) Lung Diseases

Keywords

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Polymeric Lung Volume Reduction (PLVR) Bolilogic Lung Volume Reduction (BLVR) AeriSeal treatment device breathing COPD emphysema heterogeneous homogeneous Pathologic Processes Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AeriSeal System

Not applicable. Follow-Up study only.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Soroka Medical Center

Beersheba, , Israel

Site Status

The Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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03-C10-003PLV

Identifier Type: -

Identifier Source: org_study_id