Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Result of BREAST-QTM (Quality of life) at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Result of BREAST-QTM (Quality of life) at 3 months
时间窗: 3 months after surgery
Result of BREAST-QTM (Quality of life) at 1 year
时间窗: 1 year after surgery
OR & procedure (open surgery dissection, docking and console) times, including drainage and reconstruction times
时间窗: Assessed during surgery to 6 weeks after surgery
Number of overall post-operative complications at 6 weeks
时间窗: 6 weeks after the surgery
Number of overall post-operative complications at 3 months
时间窗: 3 months after the surgery
Nipple-Areola Complex (NAC) Preservation Rate at 6 weeks after surgery
时间窗: 6 weeks after surgery
Number of transfusion and transfused units
时间窗: Assessed during surgery to 6 weeks after surgery
Number of intraoperative R-NSM procedure and device-related complications
时间窗: Assessed during surgery to 42 days after surgery
Nipple-Areola Complex (NAC) necrosis occurrence (using SKIN composite score definition of D2 or higher) observed at 6 weeks after surgery
时间窗: 6 weeks after surgery
Number of conversions to open surgery
时间窗: Assessed during surgery
Number of readmissions associated with NSM surgery at 6 weeks
时间窗: 6 weeks after surgery
Number of reoperations associated with NSM surgery at 6 weeks
时间窗: 6 weeks after surgery
Number of overall post-operative complications at 1 year
时间窗: 1 year after the surgery
Hospital Length of Stay (LOS)
时间窗: Assessed during the 6 weeks after surgery
Result of NAC questionnaire (Quality of life) at 1 year
时间窗: 1 year after surgery
Results of the SKIN score (Mayo clinic) at 6 weeks or upon surgeon's practice
时间窗: at 6 weeks or upon surgeon's practice
Number of readmissions associated with NSM surgery at 3 months
时间窗: 3 months after surgery
Number of reoperations associated with NSM surgery at 3 months
时间窗: 3 months after surgery
Result of NAC questionnaire (Quality of life) at 3 months
时间窗: 3 months after surgery
Breast Cancer Occurrence Assessment at 1 year according to usual medical practice
时间窗: 1 year after surgery
次要结局
未报告次要终点