NCT07188948招募中不适用
In Vivo Cross-Modal Imaging of Skin - VISION2
Gabriel Sanchez1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年9月2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
- 15
- 试验地点
- 1
- 主要终点
- Correlational relationship
研究概览
简要总结
The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.
详细描述
The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants, ages 2 - 90 years old
- •Participant, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.
- •Participant or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.
- •Participant and guardian, if applicable, must comply with the protocol requirements.
- •Participant or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies
排除标准
- •Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use
- •Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)
- •Any known allergies to any materials used in the preparation of skin and/or device use
- •Has a temporary or permanent electrical implanted medical device
结局指标
主要结局
Correlational relationship
时间窗: 7 days
Correlational relationship of: 1. melanin content quantified from noninvasive VIO images with 2. macroscopic skin tone as measured with a colorimeter.
次要结局
未报告次要终点
研究者
Gabriel Sanchez
CEO
Enspectra Health
研究点 (1)
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