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.

Inclusion Criteria:
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.

Exclusion Criteria:
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.
IDE
NCT02382614
Cancer, All Other
Pulmonary
Jed Gorden, M.D.
Spiration, Inc.
Andrew Smith
  • Swedish Medical Center