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The purpose of this observational study is to evaluate the safety and performance of the easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit from EziSurg Medical in gastrointestinal surgery. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications retrospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit | Device | The Staplers are available in 260mm, 350mm and 440mm lengths. Loading Units for Single Use are available in eight staple sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 2.0-2.5-3.5mm and 3.5-3.8-4.1mm, 3.8-4.1-4.4mm. |
| Measure | Description | Time Frame |
|---|---|---|
| stapling success rate | Perioperative/Periprocedura |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | Perioperative/Periprocedural | |
| Technical success rate | defined as completion of gastrointestinal surgery as intended without technical difficulties and/or without conversion to open laparotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saida Center, Lebanon | Beirut | Beirut | 1104 | Lebanon |
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|
| Perioperative/Periprocedural |