A Quantitative Optical Sensor to Monitor Vascular Physiology; A Healthy Volunteer Study
Completed
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT02321995
- Run by
- Zenalux Biomedical, Inc.
- People needed
- 10
- Starts
- 2016-06-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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