Pulmonary Air Leaks Clinical Trial
— VASTOfficial title:
Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
| NCT number | NCT02382614 |
| Other study ID # | 13 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | February 2022 |
| Verified date | March 2023 |
| Source | Olympus Corporation of the Americas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 75 |
| Est. completion date | February 2022 |
| Est. primary completion date | February 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Maryland | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | University of Texas Southwestern | Dallas | Texas |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Sparks Regional Medical Center | Fort Smith | Arkansas |
| United States | Dartmouth Mary Hitchcock Memorial Hospital | Hanover | New Hampshire |
| United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
| United States | El Camino Hospital | Mountain View | California |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Olathe Medical Center | Olathe | Kansas |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Southern Illinois University | Springfield | Illinois |
| United States | Washington Hospital Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Olympus Corporation of the Americas |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence of SAE | Six weeks | ||
| Primary | Time to Air Leak Cessation | Two weeks |