Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture/staple closure of clinically significant (Macchiarini Grade ≥1) intra-operative visceral pleural air leaks incurred during lobectomy and segmentectomy (open or minimally invasive), including those performed as video-assisted thoracic surgery (VATS), in adults.
Study Type
OBSERVATIONAL
Enrollment
250
Sealant film
Intra-operative air leaks
Air leaks successfully sealed or reduced as assessed by a submersion air leak test
Time frame: Prior to the completion of surgery
Overall device safety
Incidence of serious adverse events
Time frame: 3-months post surgery
Overall device safety
Adverse events probably or causally related to the study device
Time frame: 6-months post-surgery
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