NCT02312167已完成不适用
Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The number of participants with adverse events, their type and severity
研究概览
简要总结
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).
Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.
The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
详细描述
This study involves several innovations including :
- the robotization of the confocal miniprobe for a better an d more precise handling of the probe
- the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
- the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images
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
- •patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
- •patient able to give written informed consent
排除标准
- •allergy to fluorescein
- •allergy to patented blue
- •allergy to ICG
- •previous life-threatening allergic reactions and known hypersensitivity
- •pregnancy or breast-feeding
- •history of cardio-pulmonary disease (including bronchial asthma)
- •restricted renal function
- •patient under a beta-blockers treatment
- •patient who cannot give written informed consent
结局指标
主要结局
The number of participants with adverse events, their type and severity
时间窗: 8 months
次要结局
- The ease of manipulation of the robotized probe (grade 1 to 5)(8 months)
研究者
研究点 (2)
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