Trials / Terminated
TerminatedNCT02382614
Spiration Valves Against Standard Therapy
Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Olympus Corporation of the Americas · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Spiration Valve System |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
- First posted
- 2015-03-09
- Last updated
- 2024-04-04
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02382614. Inclusion in this directory is not an endorsement.