SciBase International Melanoma Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SciBase AB
- 入组人数
- 1,951
- 试验地点
- 4
- 主要终点
- SciBase Sensitivity and Specificity
研究概览
简要总结
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).
The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects were excluded from the study if they fulfilled any of the following criteria:
- •Skin surface not measurable, e.g. lesion on a stalk
- •Skin surface not accessible, e.g. inside ears, under nails
- •Lesion located on acral skin, e.g. sole or palms.
- •Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.
- •Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.
- •Lesion located on genitalia.
- •Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.
- •Lesion located on mucosal surfaces.
- •Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration.
- •Lesion with foreign matter, e.g. tattoo, splinter
- •Lesion and/or reference located on acute sunburn.
结局指标
主要结局
SciBase Sensitivity and Specificity
时间窗: Post data lock
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
次要结局
- Sensitivity and Specificity(Post data lock)