A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 145
- 试验地点
- 12
- 主要终点
- Primary Safety: Incidence of adverse events
研究概览
简要总结
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
详细描述
Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.
This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between ages 18-
- •Candidate for an NSM procedure.
- •At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side.
- •Breast ptosis ≤ Grade
- •Cup size ≤ C.
- •No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines.
排除标准
- •Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery.
- •Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior).
- •Current history of smoking or has smoked within 1 year of screening.
- •Skin conditions
- •Uncontrolled diabetes mellitus.
- •Previous chemotherapy or radiation
- •High risk for anesthesia or significant medical comorbidities
- •Contraindicated for general anesthesia or surgery.
- •Known bleeding or clotting disorder.
- •Pregnant or suspected to be pregnant or is lactating.
结局指标
主要结局
Primary Safety: Incidence of adverse events
时间窗: Assessed during surgery to 42 days after surgery
Incidence of intraoperative and post-operative procedure and device-related adverse events
Primary Effectiveness: No conversions to open NSM
时间窗: Assessed during surgery
Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery
次要结局
未报告次要终点