A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery 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
- 204
- 试验地点
- 15
- 主要终点
- Safety: Adverse event rates
研究概览
简要总结
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
详细描述
This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 21 or older
- •BMI < 30
- •Candidate for an NSM procedure with immediate reconstruction
- •Diagnosis of early stage brest cancer
- •Breast ptosis ≤ Grade
- •Cup size ≤ C.
排除标准
- •Previous breast surgery
- •Diagnosis of metastatic breast cancer
- •Prior radiation treatment to the chest
- •Current smokers
- •Contraindication for general anesthesia or surgery.
- •Known bleeding or clotting disorder.
- •Pregnant or suspected to be pregnant, or actively breastfeeding
研究组 & 干预措施
Robotic NSM with da Vinci SP
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
干预措施: Robotic NSM (Device)
Open NSM
Subjects randomized to this arm will undergo conventional open NSM procedures
干预措施: Open NSM (Procedure)
结局指标
主要结局
Safety: Adverse event rates
时间窗: Up to 42 days post-operatively
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Conversion rate
时间窗: Assessed during procedure
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Safety: positive surgical margin rates
时间窗: Up to 42 days post-operatively
Incidence of positive surgical margins compared to open NSM
次要结局
- Patient-Report Outcomes (BREAST-Q)(Up to 5 years)
- Oncological Outcomes (for cancer recurrence)(Up to 5 years)
- Oncological Outcomes (for disease-free survival)(Up to 5 years)
- Oncological Outcomes (for overall survival)(Up to 5 years)
- Patient-Report Outcomes (NAC Questionnaire)(Up to 5 years)
- Patient-Report Outcomes (EQ-5D)(Up to 1 year)