A Quantitative Optical Sensor to Monitor Vascular Physiology; A Healthy Volunteer Study

NCT02321995 | Completed

• 1 other identifier: Pro00057177
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• minimum contact pressure required for spectroscopic measurements

  at the time the optical measurements are collected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

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)

Sponsors & Collaborators

• Zenalux Biomedical, Inc.: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• Mark Dewhirst, DVM, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (1)