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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTVA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTVA System | Device | Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lobar volume reduction as determined by computed tomography (CT) analysis | 3 months | |
| Changes in pulmonary function therapy | 3 months | |
| Improvement in 6 minute walk distance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince Charles Hospital | Chermside | Queensland | 4032 | Australia | ||
| The Alfred Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22927751 | Derived | Herth FJ, Ernst A, Baker KM, Egan JJ, Gotfried MH, Hopkins P, Stanzel F, Valipour A, Wagner M, Witt C, Kesten S, Snell G. Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema. Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 2012 Jul 18. | |
| 22075481 |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 3 months |
| Melbourne |
| Victoria |
| 3181 |
| Australia |
| LKH Klagenfurt | Klagenfurt | 9020 | Austria |
| Otto-Wagner Hospital | Vienna | 1140 | Austria |
| Zentralklinik Bad Berka | Bad Berka | 99437 | Germany |
| Charite Campus Mitte | Berlin | 10117 | Germany |
| Thoraxklinik Heidelberg | Heildelberg | 69126 | Germany |
| Abteilung fur Pneumologie | Hemer | 58675 | Germany |
| Klinikum Nurnberg | Nuremberg | 90419 | Germany |
| Mater Misericordiae University Hospital | Dublin | 7 | Ireland |
| Snell G, Herth FJ, Hopkins P, Baker KM, Witt C, Gotfried MH, Valipour A, Wagner M, Stanzel F, Egan JJ, Kesten S, Ernst A. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012 Jun;39(6):1326-33. doi: 10.1183/09031936.00092411. Epub 2011 Nov 10. |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |