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VAST

Trial

Clinical Trial Title

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

Trial Status

Open to Enrollment

Start Date

February 28, 2017

Trial Type

Pulmonology

Specific Condition

Lung Air Leaks

Description

Investigational Device Study 

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.

 

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

IRB Number

10689

Principal Investigator Name

Jordan Fein, MD

Contact Name

Tammy Mayfield

Phone

503-413-7945

Contact Fax

503-413-6861

Contact E-Mail

tmayfiel@lhs.org

Last Updated: Wednesday, January 27, 2021 12:04:42 PM