An interventional study of treatment with valves (The Spiration® IBV Valve System) in Management of BPF (Bronchopleural Fistulae), sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Ohio State University · Not applicable, Interventional, and Other
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
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.
731 studies on the registry are indexed under Fistula; 103 are open to participants now.
Browse Fistula studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Inclusion Criteria:
Loading IBV® Valve System
Device: treatment with valves (The Spiration® IBV Valve System)
treat BPF
Also known as: spiration valve, IBV Valve System
resolution of BPF (Bronchopleural Fistulae)
expected resolution of BPF (Bronchopleural Fistulae) in three weeks
Time frame: 6 weeks
resolutin of BPF
anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks
Time frame: 6 weeks
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Ohio State University