To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.
All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Prince Charles Hospital
Chermside, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
LKH Klagenfurt
Klagenfurt, Austria
Otto-Wagner Hospital
Vienna, Austria
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
Time frame: 6 months
Lobar volume reduction as determined by computed tomography (CT) analysis
Time frame: 3 months
Changes in pulmonary function therapy
Time frame: 3 months
Improvement in 6 minute walk distance
Time frame: 3 months
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Zentralklinik Bad Berka
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Charite Campus Mitte
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Thoraxklinik Heidelberg
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Klinikum Nurnberg
Nuremberg, Germany
Mater Misericordiae University Hospital
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