AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

Aeris Therapeutics20 enrolled

Overview

The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Emphysema COPD Lung Diseases

Interventions

AeriSeal SystemDEVICE

The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted. * Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS. * Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy. Exclusion Criteria: \-

Locations (2)

The Soroka Medical Center

Beersheba, Israel

The Rabin Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

Change in Percent Volume of Lung

Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.