NCT00966173已完成不适用
An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SciBase AB
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Outcome measure not applicable. This is an algorithm training study.
研究概览
简要总结
This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Men and women of any ethnic group
- •Lesion located on normal healthy skin
- •Maximum number of eight lesions per patient
排除标准
- •Lesion under finger and toe nails
- •Lesion located on eczema, psoriasis areas or similar
- •Lesion located on scars
结局指标
主要结局
Outcome measure not applicable. This is an algorithm training study.
时间窗: Q1 2010
次要结局
未报告次要终点
研究者
研究点 (2)
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