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| Name | Class |
|---|---|
| Jinhua Municipal Central Hospital | OTHER |
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The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications.
Participants will undergoing thoracic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezisurg stapler | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thoracic surgery | Device | thoracic surgery using the easyEndoâ„¢ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis success rate | Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed. | Perioperative/Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | Perioperative/Periprocedural | |
| intra-operative blood loss | Perioperative/Periprocedural | |
| post-operative air leak |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | 321000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Perioperative/Periprocedural |
| incidence of conversion to open surgery due to stapler-related issues | Perioperative/Periprocedural |
| complication | Perioperative/Periprocedural |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |