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

Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00085852
Enrollment
6
Registered
2004-06-17
Start date
2005-04-30
Completion date
2007-06-30
Last updated
2008-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Emphysema

Keywords

emphysema, chronic obstructive pulmonary disease, lung volume reduction, bronchoscopic, bronchoscopy, bronchoscope

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICALBLVR

10 mL Hydrogel

Sponsors

Aeris Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
SAEs - Safety1 year post treatment

Secondary

MeasureTime frame
PFTs12 weeks post treatment
Dyspnea12 weeks post treatment
Exercise capacity12 weeks post treatment
QOL12 weeks post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026