NCT01104389撤回不适用
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
研究概览
简要总结
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages of 18 to 80 years.
- •Urine pregnancy test negative for women of childbearing potential prior to surgery
- •Subject is able to comply with the study procedures
- •A CT or MRI preoperative assessment of renal cortical tumor
- •The renal tumor must be stage T1a-b - T2
- •Written informed consent.
排除标准
- •Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin >1.5 X normal and/or SGOT >2X normal
- •Subject has uremia, serum creatinine >2.0 mg/dl.
- •Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- •Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- •Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- •Subject is pregnant or lactating
- •Subjects actively participating in another drug, biologic and/or device protocol
- •The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
结局指标
主要结局
The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
时间窗: Intraoperatively
The feasibility of using the fluorescence imaging on the da Vinci Surgical System to detect renal cortical tumors will be measured by the rate of good or excellent images achieved intraoperatively.
次要结局
- Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.(up to 3 weeks postoperatively)
研究者
研究点 (1)
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