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

Olympus Corporation of the Americas20 sites in 1 country75 target enrollmentMay 2015

ConditionsPulmonary Air Leaks

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Air Leaks
Sponsor: Olympus Corporation of the Americas
Enrollment: 75
Locations: 20
Primary Endpoint: Time to Air Leak Cessation
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

February 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Olympus Corporation of the Americas

Responsible Party

Sponsor

Eligibility Criteria

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.