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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with intra-operative air leak detected during lung resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TissuePatch Sealant Film | Device | Sealant film |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative air leaks | Air leaks successfully sealed or reduced as assessed by a submersion air leak test | Prior to the completion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall device safety | Incidence of serious adverse events | 3-months post surgery |
| Overall device safety | Adverse events probably or causally related to the study device |
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Inclusion Criteria:
Exclusion Criteria:
Intra-Operative Exclusion Criteria:
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Patients undergoing lung resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Contact | 4043271221 | jaime.ritter@bd.com |
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| 6-months post-surgery |