Spiration Valves Against Standard Therapy
- Conditions
- Pulmonary Air Leaks
- Interventions
- Device: Spiration Valve System
- Registration Number
- NCT02382614
- Lead Sponsor
- Olympus Corporation of the Americas
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Spiration Valve System Spiration Valve System The treatment group will have valves deployed to achieve leak isolation.
- Primary Outcome Measures
Name Time Method Time to Air Leak Cessation Two weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Olathe Medical Center
🇺🇸Olathe, Kansas, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Dartmouth Mary Hitchcock Memorial Hospital
🇺🇸Hanover, New Hampshire, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States