Spiration Valves Against Standard Therapy

Olympus Corporation of the Americas75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Air Leaks

Interventions

Spiration Valve SystemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Outcomes

Primary Outcomes

Time to Air Leak Cessation

Time frame: Two weeks

Data from ClinicalTrials.gov

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