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临床试验/NCT04566302
NCT04566302已完成不适用

Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Number of Participants With Quality Skin Images Obtained From SECM Device

研究概览

简要总结

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

详细描述

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

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

  • •Healthy adults
  • •18 years of age or older
  • •Capable of giving informed consent
  • •Pigmented lesions (such as moles) present on the forearm

排除标准

  • •Unable to provide consent
  • •Open cuts/sores on the skin, skin infection, or any contagious skin condition
  • •Pregnant women (according to subject)
  • •Employees under the direct supervision of the investigator

研究组 & 干预措施

SECM Skin Imaging

Experimental

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

干预措施: SECM Skin Imaging (Device)

结局指标

主要结局

Number of Participants With Quality Skin Images Obtained From SECM Device

时间窗: Approximate 30 minute study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Tearney

Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Massachusetts General Hospital

研究点 (1)

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