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This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted anastomoses | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted microsurgical anastomoses | Device | First in human study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: device-related adverse events (AEs) | Intraoperatively and through the 30-day post-procedure period | |
| Performance: conversion rate to manual procedure | Intraoperatively | |
| Clinical performance: vessel patency rate | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis quality (SAMS score) | The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score. | Intraoperatively |
| Anastomosis time | Duration of the full anastomosis from the moment of piercing the vessel wall for the first stitch until the thread of the last stitch is cut. |
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Inclusion Criteria:
Exclusion Criteria:
For Lymphedema patients:
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| Intraoperatively |