Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 75
- Locations
- 20
- Primary Endpoint
- Time to Air Leak Cessation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
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.
Arms & Interventions
Spiration Valve System
The treatment group will have valves deployed to achieve leak isolation.
Intervention: Spiration Valve System (Device)
Medical Management
The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed.
Outcomes
Primary Outcomes
Time to Air Leak Cessation
Time Frame: Two weeks
Secondary Outcomes
No secondary outcomes reported