Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.
Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
BLVR Treatment, 10 mL Hydrogel
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, United States
Pulmonary Associates
Phoenix, Arizona, United States
Caritas St Elizabeth's Med Cen
Boston, Massachusetts, United States
Temple University Lung Center
Philadelphia, Pennsylvania, United States
Reduction in gas trapping
Time frame: 12 weeks post treatment
SAEs - Safety of treatment and the procedure
Time frame: 2 years
Improvement in vital capacity
Time frame: 12 weeks post treatment
Improvement in expiratory flow
Time frame: 12 weeks post treatment
Improvement in inspiratory flow
Time frame: 12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)
Time frame: 12 weeks post treatment
Improvement in exercise capacity
Time frame: 12 weeks post treatment
Improvement in respiratory quality of life
Time frame: 12 weeks post treatment
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Medical University of South Carolina Hospital
Charleston, South Carolina, United States