Pulmonary Air Leaks
Conditions
Keywords
Endobronchial Valve, Minimally Invasive, Intrabronchial Valves, Digital Thoracic Drainage System, Spiration Valve System, Prolonged Air Leak, Persistent Air Leak
Brief summary
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.
Interventions
DEVICESpiration Valve System
Sponsors
Olympus Corporation of the Americas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Exclusion criteria
* Subject has air leak only on forced exhalation or cough * Subject has sepsis * Subject has pneumonia * Subject has Acute Respiratory Distress Syndrome (ARDS) * Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures * Subject has undergone a bone marrow transplant * Subject has a primary pneumothorax * Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Air Leak Cessation | Two weeks |
Other
| Measure | Time frame |
|---|---|
| Incidence of SAE | Six weeks |
Countries
United States
Outcome results
None listed