Spiration IBV® Valve System and Spiration Airway Sizing Kit
- Conditions
- Management of BPF (Bronchopleural Fistulae)
- Interventions
- Device: treatment with valves (The Spiration® IBV Valve System)
- Registration Number
- NCT01872312
- Lead Sponsor
- Ohio State University
- Brief Summary
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
- Detailed Description
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Unresolved BPF
- Not candidate for surgical repair
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment treatment with valves (The Spiration® IBV Valve System) Loading IBV® Valve System
- Primary Outcome Measures
Name Time Method resolution of BPF (Bronchopleural Fistulae) 6 weeks expected resolution of BPF (Bronchopleural Fistulae) in three weeks
resolutin of BPF 6 weeks anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OSUMC
🇺🇸Columbus, Ohio, United States