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Safety and Effectiveness of the Spiration Valve System in Air Leaks (VAST)

Phase: Pre-market Approval
Status: Not Recruiting

Purpose: To look at safety and efficacy of the investigational device, the Spiration Valve System (SVS) in treating patients with prolonged air leaks in the lungs lasting for more than five days

Study design: This is a multicenter, prospective, randomized, controlled study designed to evaluate treatment 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)

Background: Air leak from the lungs is a post-operative complication that can arise from thoracic surgical operations, including lung volume reduction surgery for patients with emphysema. Prolonged air leaks last more than 5 days can significantly increase the length of stay in the hospital, infectious complications and treatment cost. The (SVS) offers a non-surgical, minimally invasive treatment for patients who have prolonged air leaks. One or more of these valves is placed in the airways that lead to the part of the lungs that are leaking air. The valves limit the amount of air that can reach the damaged parts of the lungs, but still allows mucus to clear out of these areas. It may provide benefits including better healing and shorter length of stay in a hospital.

Inclusion Criteria Exclusion Criteria
  • Age 18 years or older
  • 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 a primary pneumothorax
  • Subject has undergone a bone marrow transplant
  • Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement

Principal Investigator

Ganesh Krishna, MD, PAMF

Sponsor

Spiration, Inc.

Contact

John Tejeda, Enterprise Senior Director for Clinical Research
Taft Center for Clinical Research
650-691-4894
John_Tejeda@elcaminohealth.org

 

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