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.
This is an observational post-market study. Women will be screened for participation where the decision to undergo prophylactic R-NSM surgery has already been made as part of their medical care. In order for women to be enrolled, surgeons must perform the surgery according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System. Women will sign an informed consent form for their participation in the study. Women will be prospectively followed at 6 weeks, 3 months and 1 year post-surgery, which is within the standard of care. Data will be collected prospectively from the medical records and women will be asked to complete preoperative and postoperative questionnaires.
Study Type
OBSERVATIONAL
Enrollment
7
Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System
Gustave Roussy Cancer Campus
Villejuif, France
Istituto Europeo di Oncologia
Milan, Italy
Number of intraoperative R-NSM procedure and device-related complications
Time frame: Assessed during surgery to 42 days after surgery
Number of overall post-operative complications at 6 weeks
Time frame: 6 weeks after the surgery
Number of overall post-operative complications at 3 months
Time frame: 3 months after the surgery
Number of overall post-operative complications at 1 year
Time frame: 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
Time frame: 6 weeks after surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
Time frame: 6 weeks after surgery
Number of conversions to open surgery
Time frame: Assessed during surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
Time frame: Assessed during surgery to 6 weeks after surgery
Number of transfusion and transfused units
Time frame: Assessed during surgery to 6 weeks after surgery
Hospital Length of Stay (LOS)
Time frame: Assessed during the 6 weeks after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
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Time frame: at 6 weeks or upon surgeon's practice
Number of readmissions associated with NSM surgery at 6 weeks
Time frame: 6 weeks after surgery
Number of readmissions associated with NSM surgery at 3 months
Time frame: 3 months after surgery
Number of reoperations associated with NSM surgery at 6 weeks
Time frame: 6 weeks after surgery
Number of reoperations associated with NSM surgery at 3 months
Time frame: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 3 months
Time frame: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
Time frame: 1 year after surgery
Result of NAC questionnaire (Quality of life) at 3 months
Time frame: 3 months after surgery
Result of NAC questionnaire (Quality of life) at 1 year
Time frame: 1 year after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
Time frame: 1 year after surgery