Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Proportion of lesions with semiological characteristics
研究概览
简要总结
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.
This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.
This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
- •skin lesion belonging to one of these groups (diagnosed by clinical examination):
- •cutaneous cyst
- •seborrhoeic keratosis
- •cutaneous carcinoma
- •actinic keratosis and cutaneous horn
- •other skin tumors
- •skin lesion size equal to or less than 5 cm
- •signed written consent form
- •patient affiliated to a social insurance
排除标准
- •skin lesion size strictly over than 5 cm
- •eyelid lesion
- •aluminium, POM (polyoxymethylene) or organic glass allergy
- •known pregnancy, breast-feeding
结局指标
主要结局
Proportion of lesions with semiological characteristics
时间窗: Before biopsy
Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
次要结局
- Number of different semiological characteristics(Before biopsy)
- Physico-optical description of the lesions(Before biopsy)
- Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis(Before biopsy)
- Proportion of semiological characteristics properly identified(Before biopsy)
- Specificity, sensitivity and predictive values(Before biopsy)