NCT03049280已完成不适用
A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Number of Subjects With Device-related Serious Adverse Events
研究概览
简要总结
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
详细描述
A prospective, multicenter investigation to evaluate the safety and clinical performance of the da Vinci SP Surgical System, instruments, and accessories in TORS procedures for malignant oropharyngeal tumors classified as T1 and T2.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •T1 or T2 malignant oropharyngeal tumor
- •Tumor amenable to transoral resection
- •No previous treatment for the index tumor
- •Willing and able to provide written informed consent
- •Willing and able to comply with the study protocol requirements
排除标准
- •T3 or T4 stage tumor
- •Previous radiation treatment to the head and neck, with or without chemotherapy
- •Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers
- •Pre-operative expectation of needing microvascular soft-tissue reconstruction
- •Tumor that invades and/or abuts the internal and/or external carotid artery
- •Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer
- •Evidence of mandibular invasion of tumor
- •Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2
- •On a medication that interferes with clotting that cannot be stopped prior to surgery
- •Contraindication for general anesthesia or surgery
- •Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- •Pregnant or suspected to be pregnant
结局指标
主要结局
Number of Subjects With Device-related Serious Adverse Events
时间窗: Intraoperative period
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Performance
时间窗: Intraoperative
Performance defined as the conversion to an open approach required to complete the procedure
次要结局
- Positive Surgical Margin(Through14-days postoperatively)
研究者
研究点 (6)
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