Clinical trial NCT02382614: Spiration Valves Against Standard Therapy
Official title: Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Air Leaks
Keywords: Endobronchial Valve
Minimally Invasive
Intrabronchial Valves
Digital Thoracic Drainage System
Spiration Valve System
Prolonged Air Leak
Persistent Air Leak
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to Air Leak Cessation
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
measure: Incidence of SAE
timeFrame: Six weeks
Locations:
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Olathe
country: United States
facility: Olathe Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Hanover
country: United States
facility: Dartmouth Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: