Purpose of this Study
People in the study will have one visit that lasts about 20 minutes. During this visit, the researchers will ask for basic information like age, gender, and race or ethnicity. They will also look at skin color using a special chart called the Monk Skin Tone scale.
Next, trained workers will use a small device called the InfraScanner 2500TM to check different parts of the head. These parts include the front, sides, and back. The device is safe, approved by the FDA, and does not use harmful radiation. It uses light to do its job and does not hurt. This study does not give medicine, does not pick people randomly, and does not share test results with the participants.
Who Can Participate?
Eligibility
You can join this study if you are 18 years old or older and are a healthy adult. You must be a student, staff member, or employee at Duke University or Duke University Medical Center. You cannot have had any head injuries, brain surgery, bleeding inside the head, or brain growths. Your scalp must be healthy, and your hair cannot block the device. You also need to agree to take part and be able to sit still for a short and safe scanning procedure.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
The goal of this study is to learn if skin color changes how well the InfraScanner 2500 can find bleeding inside the head. The InfraScanner is a small device that uses light and does not use radiation, so it is safe. What we learn could help make the device work the same for everyone, no matter their skin color.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Effect of Skin Tone on the Diagnostic Performance of the InfraScanner 2500TM: A Controlled Validation Study
Principal Investigator
Bradley
Kolls
Protocol Number
PRO00119438
Enrollment Status
Pending Open to Enrollment