MDT23038INSENS (Blood Oxygen Levels in Healthy Volunteers)

MDT23038INSENS (Blood Oxygen Levels in Healthy Volunteers)

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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.

Who Can Participate?

Eligibility

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 Range

18-50

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes

What is Involved?

Description

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

Locations

Pickett Road Research

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

David
MacLeod

Protocol Number

PRO00115806

NCT ID

NCT06581835

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov