Pleural Effusion Clinical Trial
Official title:
Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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