Evaluation of the Medical Device ex Vivo ENDOSWIR in Patient Operated for a Tonsillectomy : a Preliminary Cohort Study Proof of Concept (ENDOSWIR-AMYG)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tissue integrity
研究概览
简要总结
Head and neck cancer has an incidence of 600,000 cases per year worldwide (6th among cancers) and cause 380,000 death per year. Surgical resection is guided by the surgeon's inspection and palpation of the tumor. The prognosis of patients depends on the quality of the lesion's resection. The ENDOSWIR dispositive developed by engineers of Atomic Energy Comity of Grenoble allows for reliable and accurate analysis of tumor margins.
The camera provides a spectral analysis of the tissues according to their composition. We want to show that the prognosis of patients is improved by the use of this device. For that we need to prove first that it is not toxic for tissue analysis.
详细描述
ENDOSWIR dispositive is a InGaAs (Indium Gallium Arsenide) camera working at ambient temperature. The light is a quartz-tungstene-halogeno (QTH) source and the collected beam is filtered to illuminate in different precise wavelength bands in the short wave domain.
We will use it on tonsil tissue just after tonsillectomy and just before the histological analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Tonsillectomy
排除标准
- •suspicion of Head-and neck cancer
结局指标
主要结局
Tissue integrity
时间窗: 1 day
Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue
次要结局
未报告次要终点