Vanderbilt Clinical Trials

Spiration Valves Against Standard Therapy

Purpose

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.

Condition

Pulmonary Air Leaks

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Spiration Valve System	The treatment group will have valves deployed to achieve leak isolation.	Device: Spiration Valve System
No Intervention Medical Management	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.

More Details

Status: Terminated
Sponsor: Olympus Corporation of the Americas

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.