Spiration Valves Against Standard Therapy

Stopped early · Not applicable

Conditions studied: Pulmonary Air Leaks

In brief

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.

Key facts

Study ID

NCT02382614

Run by

Olympus Corporation of the Americas

People needed

75

Starts

2015-05-01

Expected to finish

2022-02-01

Last updated by the study team

2024-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• El Camino Hospital — Mountain View, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Southern Illinois University — Springfield, Illinois, United States
• Olathe Medical Center — Olathe, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Dartmouth Mary Hitchcock Memorial Hospital — Hanover, New Hampshire, United States
• Cooper University Hospital — Camden, New Jersey, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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