Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
研究概览
简要总结
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods:
- Ruler using the Kundin method,
- Investigational software Clinicgram Euclides
- Digital planimetry with Adobe Photoshop
The clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.
详细描述
The aim of the clinical investigation EUCLIDES-01 is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three skin lesion area measurement methods:
- Ruler using the Kundin method,
- Investigational software Clinicgram Euclides
- Digital planimetry with Adobe Photoshop
Clinicgram Euclides is a software that allows automatic calculation of skin lesion areas using a mobile device. It has two modes of operation (Euclides 2D and Euclides 3D).
The sample size is 65 subjects. Up to three skin lesions can be included from the same subject. For this reason, the number of subjects may be smaller if more than one skin lesion is measured in certain subjects.
EUCLIDES-01 is a pre-market, prospective, single-center, non-randomized clinical investigation with one arm of subjects intended to collect skin lesion area data for the comparison of the agreement among the results obtained between the three above-mentioned skin lesion area measurement methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •The subject must give written informed consent prior to any procedure related to the clinical investigation.
- •Adult person 18 years of age or older.
- •The subject has an external skin lesion whose length and width can be measured with a 15-centimeter ruler.
- •The subject's external skin lesion can be measured with a perpendicular camera approach (90 degrees).
- •The subject has an external skin lesion located in an area that does not include an edge or curvature of the body, and that has no parts hidden by any device or treatment.
- •The subject has one or more isolated skin lesion(s) that allows for an individual capture and analysis process for each lesion.
- •Subjects are able to tolerate changes in position for at least 2 minutes in the area where the skin lesion is located.
- •Subjects can hold still, or not be prevented by pain from having still, for at least 10 seconds for the taking of the skin lesion photograph.
排除标准
- •The subject is currently participating in another clinical investigation.
- •Pregnant or breastfeeding women. Subjects who have medical, social, or psychological conditions that, in the opinion of the investigator, could limit the subject's ability to participate in the investigation or impact the scientific robustness of the clinical investigation results.
- •Subjects who have neoplastic, tumor, or pre-cancerous skin lesions.
- •Subjects presenting skin carcinomas or other skin lesions of confirmed malignancy (after differential diagnosis and screening of the potentially malignant lesion by clinical gross dermatology, dermatoscopy, microscopic dermatopathology, biopsy, or similar).
- •Subjects presenting skin lesions with excessive exudate that may obscure part of the skin lesion and its outline.
- •Subjects who suffer from movement disorders in the area where the skin lesion is located.
- •Subjects who may have allergies to the plastic of the external caliper or other skin irritations.
结局指标
主要结局
Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
时间窗: 1 day
To assess the reproducibility of Clinicgram Euclides in the e of skin lesion area measurements using two different mobile devices: an iPhone and an iPad.
Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
时间窗: 1 day
To assess the repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two consecutive measurements performed by the same investigator.
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
时间窗: 1 day
To assess the agreement/concordance of skin lesion area measurements between: * the investigational software Clinicgram Euclides and digital planimetry using Adobe Photoshop, and * the investigational software Clinicgram Euclides and the ruler measurement using the Kundin method.
次要结局
- Usability of the investigational software Clinicgram Euclides.(1 day (at the end of the study))