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Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobronchial valves (EBV) | Active Comparator | Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves |
|
| Intrabronchial valves (IBV) | Active Comparator | Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV implantation | Device | In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pulmonary function (FEV1 and RV/TLC) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe adverse events | 6 months | |
| Evaluation of valve migration rate | 6 months | |
| Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2022 | |
| Reset | Jul 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2022 | Jul 7, 2023 |
| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
|
| IBV implantation | Device | In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. |
|
|
| 6 months |
| Average changes in 6-minute-walk-distance | 6 months |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |