NCT06666790招募中不适用
DermaSensor Postmarket Surveillance Study
DermaSensor, Inc.4 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2024年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 4
- 主要终点
- Device Sensitivity
研究概览
简要总结
The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
Investigator unaided (i.e., blinded/masked) assessment followed by aided assessment of each lesion's malignancy risk.
入排标准
- 年龄范围
- 40 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 40 and older
- •Primary skin lesion suspicious for melanoma
- •Patient is willing and able to read, understand, and sign the informed consent form (ICF)
排除标准
- •Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
- •Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
- •Lesion is greater than 15mm in diameter at the widest point.
- •Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.
- •Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
- •Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).
- •Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
- •Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).
- •Lesion is located on acral skin (e.g., sole or palms).
- •Lesion is located within 10mm of the eye.
- •Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
- •Lesion is located on mucosal surfaces (e.g. genitals, lips).
- •Lesion is located in an area with acute sunburn.
- •Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits
结局指标
主要结局
Device Sensitivity
时间窗: 39 months
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic BlocksDisorder, Sympathetic NerveNCT02390323Hospital for Special Surgery, New York13
已完成
不适用
Study of Skin and Muscle Parameters Using a Skin SensorSkin WoundsNCT01722929Northwestern University4
已完成
不适用
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin CancerSkin CancerNCT06690086DermaSensor, Inc.1,028
已完成
不适用
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol ConcentrationThe Sweat Alcohol ConcentrationNCT02860195Assistance Publique Hopitaux De Marseille6
已完成
不适用
MaxAn Post Market Surveillance ValidationDeformityFractureTumorDDDNCT01343693Zimmer Biomet119