NCT06690086已完成不适用
DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
DermaSensor, Inc.1 个研究点 分布在 1 个国家目标入组 1,028 人开始时间: 2020年8月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,028
- 试验地点
- 1
- 主要终点
- Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
研究概览
简要总结
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
详细描述
A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of any ethnic group aged 22 and older
- •Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
- •Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)
排除标准
- •Lesion < 2.5mm in diameter or > 15mm in diameter
- •Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
- •Lesion on area of crust, psoriasis, eczema or similar skin condition
- •Lesion has erosion and/or ulceration with no area >2.5mm intact
- •Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
- •Lesion in which the device tip cannot be placed entirely within the border of the targeted area
- •Lesion located on acral skin (e.g. sole or palms)
- •Lesion located within 1 cm of the eye
- •Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
- •Lesion located on mucosal surfaces (e.g. genitals, lips)
- •Lesion located on acute sunburn
- •Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
- •Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent
结局指标
主要结局
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
时间窗: Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
时间窗: Day 1
次要结局
- Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%(Day 1)
研究者
研究点 (1)
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