NCT04705168已完成不适用
Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Electrical impedance spectroscopy scores of participants' nevi
研究概览
简要总结
The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 30 years of age) at the time of the initial study visit.
- •Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.
- •Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.
- •Patients (or LAR) who are able to provide informed consent.
- •Patients with previous total body photography images taken at least 3 years prior
排除标准
- •Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.
- •Patients with any electronic implantable devices.
- •Patients who are pregnant (verbally confirmed with the participant).
结局指标
主要结局
Electrical impedance spectroscopy scores of participants' nevi
时间窗: 2 weeks
The primary objective is to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter.
次要结局
未报告次要终点
研究者
研究点 (3)
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