Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

Conditions
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Prophylactic Nipple Sparing Mastectomy (NSM)

Intervention / Treatment
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* Procedure: Nipple-Sparing Mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a woman, candidate for a prophylactic R-NSM surgical procedure (unilateral or bilateral) according to the Instructions For Use (IFU) of da Vinci Xi/X Surgical System Subject has cup size A, B or C, Subject is 18 years of age or older, Subject is a candidate for reconstruction, Subject is willing to participate as demonstrated by signing the informed consent, Subject benefits from a health care system/insurance. Exclusion Criteria: Subject is pregnant or is lactating, Subject has active cancer or pre-cancer (Ductal Carcinoma In Situ [DCIS]) on breast to be robotically operated, Subject has cancer involving the Nipple Areolar Complex (NAC), inflammatory breast cancer or T4d lesion, clinical evidence of skin involvement or T4b lesion, and clinical or radiological evidence of chest wall invasion. Subject has ASA score ˃ III or has known thromboembolism risks or, is at risk in relation to anesthesia, Subject presents severe lack of cooperation due to psychological or severe systemic illness, Subject has medical conditions contraindicating general anesthesia or surgical approach, Subject is part of vulnerable population (e.g., prisoners, mentally disabled).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylactic Nipple-Sparing Mastectomy<br> | Procedure: Nipple-Sparing Mastectomy<br>* Nipple-Sparing Mastectomy using da Vinci X/Xi Surgical System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intraoperative R-NSM procedure and device-related complications |  | Assessed during surgery to 42 days after surgery | 
| Number of overall post-operative complications at 6 weeks |  | 6 weeks after the surgery | 
| Number of overall post-operative complications at 3 months |  | 3 months after the surgery | 
| Number of overall post-operative complications at 1 year |  | 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 |  | 6 weeks after surgery | 
| Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery |  | 6 weeks after surgery | 
| Number of conversions to open surgery |  | Assessed during surgery | 
| OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times |  | Assessed during surgery to 6 weeks after surgery | 
| Number of transfusion and transfused units |  | Assessed during surgery to 6 weeks after surgery | 
| Hospital Length of Stay (LOS) |  | Assessed during the 6 weeks after surgery | 
| Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice |  | at 6 weeks or upon surgeon's practice | 
| Number of readmissions associated with NSM surgery at 6 weeks |  | 6 weeks after surgery | 
| Number of readmissions associated with NSM surgery at 3 months |  | 3 months after surgery | 
| Number of reoperations associated with NSM surgery at 6 weeks |  | 6 weeks after surgery | 
| Number of reoperations associated with NSM surgery at 3 months |  | 3 months after surgery | 
| Result of BREAST-QTM (Quality of life) at 3 months |  | 3 months after surgery | 
| Result of BREAST-QTM (Quality of life) at 1 year |  | 1 year after surgery | 
| Result of NAC questionnaire (Quality of life) at 3 months |  | 3 months after surgery | 
| Result of NAC questionnaire (Quality of life) at 1 year |  | 1 year after surgery | 
| Breast Cancer Occurrence Assessment at 1 year according to usual medical practice |  | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot, robotic, Nipple Sparing Mastectomy, NSM, da Vinci, surgery, mastectomy, prophylactic NSM, robot-assisted