DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Barco NV
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
研究概览
简要总结
This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •The patient has a lesion that is accessible to the Barco Digital Dermatoscope
- •Patient gives informed consent
- •Men or women of any ethnic group aged ≥ 18 years
排除标准
- •Men or women of any ethnic group aged < 18 years
- •Patients not willing or able to read, understand and sign the study-specific informed consent form
结局指标
主要结局
Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
时间窗: 3.5 years
Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography
次要结局
- Comparison of new device to standard dermoscopy(2 years)