US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

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Detailed Description

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Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Conditions

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Pulmonary Emphysema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single

Treatment with BLVR

Group Type EXPERIMENTAL

BLVR

Intervention Type BIOLOGICAL

10 mL Hydrogel

Interventions

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BLVR

10 mL Hydrogel

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Advanced emphysema
* Limited exercise capacity and persistent symptoms despite medical therapy
* Age between 18 and 75
* No significant heart, kidney or liver disease
* Willingness and ability to tolerate bronchoscopy
* No prior Lung Volume Reduction Surgery or Lung Transplantation
* Screening test results indicating that the procedure is appropriate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No