Stopped: Low enrolment
The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.
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Number of intraoperative R-NSM procedure and device-related complications
Timeframe: Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks
Timeframe: 6 weeks after the surgery
Number of overall post-operative complications at 3 months
Timeframe: 3 months after the surgery
Number of overall post-operative complications at 1 year
Timeframe: 1 year after the surgery
Nipple-Areola Complex (NAC) necrosis occurrence (using SKIN composite score definition of D2 or higher) observed at 6 weeks after surgery
Timeframe: 6 weeks after surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
Timeframe: 6 weeks after surgery
Number of conversions to open surgery
Timeframe: Assessed during surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
Timeframe: Assessed during surgery to 6 weeks after surgery
Number of transfusion and transfused units
Timeframe: Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)
Timeframe: Assessed during the 6 weeks after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
Timeframe: at 6 weeks or upon surgeon's practice
Number of readmissions associated with NSM surgery at 6 weeks
Timeframe: 6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months
Timeframe: 3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks
Timeframe: 6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months
Timeframe: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months
Timeframe: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
Timeframe: 1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months
Timeframe: 3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year
Timeframe: 1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
Timeframe: 1 year after surgery