NCT02321995已完成不适用
A Quantitative Optical Sensor to Monitor Vascular Physiology; A Healthy Volunteer Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- minimum contact pressure required for spectroscopic measurements
研究概览
简要总结
This study aims to evaluate the Zenalux IM1, an optical spectroscopy device with a pressure sensor. The pressure sensor is intended to overcome the inconsistencies attributable to variations in use of the device. This study will involve using the device on healthy volunteers. Three tissue parameters will be used to analyze the pressure effects in two ways: within- and across-subject variability. Measurements will be taken under the tongue and on the inside of the cheek. The device is noninvasive and is approved for preclinical use.
详细描述
PURPOSE OF THE STUDY:
- There exist significant systematic and random errors in the in vivo spectroscopic measurement of tissue hemoglobin concentrations, blood oxygenation, and scattering coefficient due to uncontrolled probe-to-tissue interface and the lack of a real-time calibration.
- It is possible to design and engineer a fiber optic sensor to perform accurate and reproducible diffuse reflectance spectroscopy (DRS) for noninvasive quantification of tissue physiology and morphology in vivo. Features such as probe pressure control and instrument self-calibration will improve signal-to-noise ratios by removing user bias from optical measurements.
STUDY OBJECTIVES
- Evaluation of the pressure sensor in healthy volunteers to determine the minimum contact pressure required for spectroscopic measurements
DESIGN AND PROCEDURES:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer with no presentation of disease (such as no complaints or self-reported oral symptoms or lesions; no cold or flu like symptoms) that would affect the reflective measurements in the oral cavity
- •Age 18 or older
- •Subjects of all ethnic and gender groups will be included
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Subjects considered in "vulnerable" populations such as children under the age of 18
- •Complaint of oral symptoms or lesions
- •Current cold or flu like symptoms (self-reported)
- •Pregnancy (self-reported by menstrual history)
结局指标
主要结局
minimum contact pressure required for spectroscopic measurements
时间窗: at the time the optical measurements are collected
次要结局
未报告次要终点
研究者
研究点 (1)
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