Spiration Valves Against Standard Therapy (VAST)

Olympus

Status: Terminated

Conditions: Pulmonary Air Leaks

Treatments: Device: Spiration Valve System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382614

13

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Spiration Valve System

Experimental group

Description:

The treatment group will have valves deployed to achieve leak isolation.

Treatment:

Device: Spiration Valve System

Medical Management

No Intervention group

Description:

The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed.