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| Name | Class |
|---|---|
| Olympus Corporation of the Americas | INDUSTRY |
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Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bilateral | Active Comparator | Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use Intrabronchial Valves™ |
|
| unilateral | Active Comparator | Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pulmonary function (FEV1) 6-minute walking test | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of major complications(SAE) | 3 months | |
| Evaluation of the IBV migration rate | 3 months | |
| Average changes in quality of life (SGRQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix JF Herth, MD | Contact | +49 6221 396 | 1200 | Felix.Herth@thoraxklinik-heidelberg.de |
| Ralf Eberhardt, MD | Contact | +49 6221 396 | 1204 | Ralf.Eberhardt@rthoraxklinik-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Felix JF Herth, MD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik Heidelberg | Recruiting | Heidelberg | 69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19662969 | Background | Venuta F, Rendina EA, Coloni GF. Endobronchial treatment of emphysema with one-way valves. Thorac Surg Clin. 2009 May;19(2):255-60, x. doi: 10.1016/j.thorsurg.2009.04.002. | |
| 19131539 | Background | Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. doi: 10.1513/pats.200809-114GO. |
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| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration |
|
|
| 3 months |
| Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) | 3 months |
| 18453355 | Background | Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. doi: 10.1513/pats.200707-085ET. |
| 22459779 | Derived | Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |