NCT00995852

Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Unilateral vs. Bilateral IBV Placement

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Detailed description

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.

Conditions

• Pulmonary Emphysema

Interventions

Type	Name	Description
DEVICE	IBV Implantation	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
DEVICE	IBV Implantation	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

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-10-15
• Last updated: 2011-04-27

Locations

1 site across 1 country: Germany