This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
First in human study
Safety: device-related adverse events (AEs)
Time frame: Intraoperatively and through the 30-day post-procedure period
Performance: conversion rate to manual procedure
Time frame: Intraoperatively
Clinical performance: vessel patency rate
Time frame: Intraoperatively
Anastomosis quality (SAMS score)
The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score.
Time frame: 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.
Time frame: Intraoperatively
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