A Phase 1 interventional study of BLVR in Pulmonary Emphysema, sponsored by Aeris Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-03-06.
Sponsored by Aeris Therapeutics · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 6 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Aeris Therapeutics is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Treatment with BLVR
Biological: BLVR
10 mL Hydrogel
SAEs - Safety
Time frame: 1 year post treatment
PFTs
Time frame: 12 weeks post treatment
Dyspnea
Time frame: 12 weeks post treatment
Exercise capacity
Time frame: 12 weeks post treatment
QOL
Time frame: 12 weeks post treatment
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Aeris Therapeutics