NCT06561646尚未招募不适用
A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Local recurrence free survival rate
研究概览
简要总结
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Male breast cancer or inflammatory breast cancer;
- •Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
- •The clinical data is basically incomplete;
- •Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
- •Bilateral breast cancer surgery;
- •Other surgical methods;
- •Preoperative distant metastasis or supraclavicular lymph node dissection;
- •Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
- •The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
- •Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
结局指标
主要结局
Local recurrence free survival rate
时间窗: Ten years
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
次要结局
未报告次要终点
研究者
研究点 (1)
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