Endoscopic Breast Surgery Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer
研究概览
简要总结
RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.
详细描述
PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- •Breast disease (e.g., fibroadenoma, ADH)
- •Ability to read and/or comprehend consent form and questionnaires
- •Ability to follow-up per protocol
- •Not pregnant or breastfeeding
排除标准
- •Pregnant or breastfeeding
- •Evidence of chest wall or skin* involvement
- •NOTE: *may be endoscopy-assisted
结局指标
主要结局
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer
时间窗: 5 years
次要结局
- To evaluate the safety, breast cosmesis and patient quality of life following EBS(After completion of study treatment)