Development and Validation of a New Digital Dermatoscope in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Barco NV
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Safety of the new device in its normal conditions of use
研究概览
简要总结
A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Male or Female, aged less than 18 years, with informed consent of their legally authorized representative.
- •Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging.
- •Able and willing to comply with all study requirements.
- •Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis.
排除标准
- •Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent.
- •Patients unable to provide informed consent.
- •Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site.
- •Lesion is at a site where previous surgery was undertaken.
结局指标
主要结局
Safety of the new device in its normal conditions of use
时间窗: 1 year
The number of adverse events will be reported to assess safety of the device.
Performance of the new device in its normal conditions of use
时间窗: 6 months
The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree.
Usability of the new device
时间窗: 1 month
The outcome will be measured by a questionnaire with usability-related questions for clinicians.
次要结局
- Develop a database of skin images with the new device with metadata and histopathology of excised lesions(1 year)