Study Stopped
business reasons
Spiration Valves Against Standard Therapy
VAST
Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
1 other identifier
interventional
75
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedApril 4, 2024
March 1, 2023
6.8 years
March 3, 2015
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Air Leak Cessation
Two weeks
Other Outcomes (1)
Incidence of SAE
Six weeks
Study Arms (2)
Spiration Valve System
EXPERIMENTALThe treatment group will have valves deployed to achieve leak isolation.
Medical Management
NO INTERVENTIONThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
El Camino Hospital
Mountain View, California, 94040, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Southern Illinois University
Springfield, Illinois, 62794, United States
Olathe Medical Center
Olathe, Kansas, 66061, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Dartmouth Mary Hitchcock Memorial Hospital
Hanover, New Hampshire, 03755, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Swedish Medical Center
Seattle, Washington, Jed Gorden, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 9, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
April 4, 2024
Record last verified: 2023-03