Clinical Trial Title Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks (VAST)
Trial Status Open to Enrollment
Start Date 02/28/2017
Location legacy-good-samaritan-medical-center
Trial Type Pulmonology
Specific Condition Lung Air Leaks

Investigational Device Study 

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.


Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
  • Subject has air leak present on at least the 5th day following origination.
IRB Number 10689
Principal Investigator Jordan Fein, MD
Contact Name Tammy Mayfield
Contact Phone 503-413-7945
Contact Fax 503-413-6861
Contact E-Mail