SHS_492286 GORJ CSPI 15163
Safety and Effectiveness of the Spiration Valve System in Air Leaks
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.
Air leak ? 100 mL/min, as measured by a digital thoracic drainage system (DTDS). Air leak present on at least the 5th day following origination.
Air leak only on forced exhalation or cough. Sepsis. Pneumonia. Acute Respiratory Distress Syndrome (ARDS). Is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures. Undergone a bone marrow transplant. Has a primary pneumothorax. Undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
Jed Gorden, M.D.