This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
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The primary endpoint is to confirm the non-inferiority of the rate of specific intraoperative adverse events compared to the rates reported in the literature.
Timeframe: During surgery (intraoperative)
Ability to complete the procedure as planned, using the device
Timeframe: During surgery
Siegfried Priglinger, Univ. Prof. Dr. med.