NCT06663241已完成不适用
Validation of New Photographic Technology for Assessing Skin Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of matching dermatologic diagnoses from photography to biopsied lesions.
研究概览
简要总结
The purpose of this study is to determine the validity of a new photographic technology in a dermatologic setting. The digital picture uses high levels of resolution to look at skin biopsy lesions. These photos will be compared to current standard-of-care with hematoxylin and eosin histologic analysis by board-certified dermatologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult patients ages 18 and older.
- •Able to comprehend procedures, risks, and informed consent.
- •Have a skin lesion the practitioner believes, and subject agrees, should be biopsied.
- •Lesion on a non-revealing part of the body (none on areas that would be recognizable, nor on groin nor breasts).
- •Willingness of subject to share the results of the biopsy pathology.
排除标准
- •Lesion on a revealing part of body.
- •Unable to understand the procedures, informed consent.
结局指标
主要结局
Number of matching dermatologic diagnoses from photography to biopsied lesions.
时间窗: At time of biopsy procedure of the lesion.
A group of board-certified dermatologists will evaluate the standard digital vs. enhanced digital photograph of the lesion to compare the accuracy of diagnoses to the pathology report, with pathology serving as the gold standard.
次要结局
未报告次要终点
研究者
研究点 (1)
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