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This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment plus Optimal Medical Therapy | Experimental | Patients will be treated with the InterVapor System and Optimal Medical Therapy |
|
| Optimal Medical Therapy | Active Comparator | Patients will be treated according to Optimal Medical Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterVapor® treatment plus Optimal Medical Therapy | Device | Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary). |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1-second (FEV1) compared to active comparator | Year 1 | |
| Quality of Life (SGRQ) | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate for FEV1 % difference from baseline | Year 1 | |
| Responder rate SGRQ pts difference from baseline | Year 1 | |
| Responder rate 6MWD meter difference from baseline |
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Inclusion Criteria:
Exclusion Criteria:
More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
FEV1 < 20% predicted
DLCO < 20% predicted or immeasurable DLCO
Body mass index (BMI) < 18kg/m2 or > 32 kg/m2
History of any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Felix JF Herth, MD | Heidelberg University | Principal Investigator |
| Gregory Snell, MD | The Alfred Hospital, Melbourne, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince Charles Hospital | Chermside | Queensland | 4032 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26899390 | Derived | Herth FJ, Valipour A, Shah PL, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, McNulty WH, Petermann C, Snell G, Gompelmann D. Segmental volume reduction using thermal vapour ablation in patients with severe emphysema: 6-month results of the multicentre, parallel-group, open-label, randomised controlled STEP-UP trial. Lancet Respir Med. 2016 Mar;4(3):185-93. doi: 10.1016/S2213-2600(16)00045-X. Epub 2016 Feb 16. | |
| 25500669 |
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|
|
| Optimal Medical Therapy | Other | Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary). |
|
| Year 1 |
| Lobar Volume Reduction HRCT | Year 1 |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Otto-Wagner-Spital | Vienna | 1140 | Austria |
| Charite Universitätsmedizin Berlin Campus Mitte | Berlin | 10117 | Germany |
| Gemeinschaftskrankenhaus Havelhöhe Berlin | Berlin | 14089 | Germany |
| Asklepios Fachkliniken Gauting München | Gauting | 82131 | Germany |
| Klinik Schillerhohe | Gerlingen | Germany |
| Universitätsklinik Halle | Halle | Germany |
| Asklepios Klinik Harburg | Hamburg | 21075 | Germany |
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Klinikum Nürnberg | Nuremberg | 90419 | Germany |
| Mater Misericordiae University Hospital | Dublin | 7 | Ireland |
| Auckland City Hospital | Auckland | 1051 | New Zealand |
| Royal Bromptom & Harefield NHS Foundation | London | United Kingdom |
| Derived |
| Bandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ. Segmental approach to lung volume reduction therapy for emphysema patients. Respiration. 2015;89(1):76-81. doi: 10.1159/000369036. Epub 2014 Dec 6. |
| 25467378 | Derived | Valipour A, Herth FJ, Eberhardt R, Shah PL, Gupta A, Barry R, Henne E, Bandyopadhyay S, Snell G. Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study. BMC Pulm Med. 2014 Dec 3;14:190. doi: 10.1186/1471-2466-14-190. |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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