TerminatedNot Applicable

Spiration Valves Against Standard Therapy

Stopped: business reasons

United States75 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time to Air Leak Cessation

Timeframe: Two weeks

Trial details

NCT IDNCT02382614

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02

View on ClinicalTrials.gov More Pulmonary Air Leaks trials