MDT23038INSENS (Blood Oxygen Levels in Healthy Volunteers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a study device, called the Medtronic INVOS PM7100 Cerebral Oximetry Monitor, is accurate. This device measures how much oxygen is in your brain.

What is the Condition Being Studied?

Healthy Volunteers

Who Can Participate in the Study?

Adults ages 18-50 who:

  • Are in good general health
  • Do not take daily medications (dietary supplements, birth control, and seasonal allergy medications are allowed)
  • Do not have any heart or breathing conditions
  • Can pass a urine drug screen (includes testing for Delta-8 and -9 THC metabolites)
  • Do not smoke, vape, or use any other nicotine product

For more information about who can join this study, please contact the study team at taylor.t.brown@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will make 2 visits to our clinic. The first visit will last about 2 hours and confirm whether or not you are eligible to participate. The second visit will last about 4 hours.

During the second visit, we will see how well the study device works. We will test it by making your body temporarily have low oxygen. You will wear sensors on your fingers and forehead while breathing air with less oxygen.

Also, small tubes will be put into your forearm and neck to get blood samples. We'll check how much oxygen is in these samples. Then, we'll compare these results with what the study device shows. The study device has been approved by the FDA.

We will pay you for your time on the study. The study's compensation is as follows:

  • Compensation for first visit: $75 ($100 if you are not eligible to come in for the second visit)
  • Compensation for second visit: $1125

Study Details

Full Title
Accuracy performance verification of the INVOS? PM7100 System by comparing rSO2 values to reference blood oxygen saturation measurements in adult human volunteers.
Principal Investigator
Protocol Number
IRB: PRO00115806
NCT: NCT06581835
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment