Microwave Ablation of Breast Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
研究概览
简要总结
The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.
详细描述
Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
- •Tumor is palpable or visible on ultrasound or both
- •All participants need to be fully able to give informed consent
排除标准
- •Gender: male
- •Mental or legal incompetence
- •Impaired decision-making capacity
- •Pregnant women may not participate
- •Implanted Pacemaker
结局指标
主要结局
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
时间窗: 30 days
Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction.
次要结局
- Amount of toxicity of microwave ablation in patients.(30 Days)
- Provide the differences between percutaneous and open Microwave Ablation(30 Days)