NCT00601185已完成不适用
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 4
- 主要终点
- is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
研究概览
简要总结
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
- •The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope.
- •Ability to sign informed consent.
- •Age ≥ 18 years.
排除标准
- •Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
- •Inability to give informed consent.
- •Known hypersensitivity to adhesive rings.
- •Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).
结局指标
主要结局
is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
时间窗: conclusion of study
次要结局
- To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection.(conclusion of study)
研究者
研究点 (4)
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