Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03610269
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Subject has given written informed consent to participate in the study
Exclusion Criteria:
* (\*) Pregnant or positive human chorionic gonadotropin (hCG) test
* (\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis
* (\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)
* (\*) Subjects who are currently taking anticoagulant medication
* (\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic
* (\*) Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
* (\*) Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
* (\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.
* (\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw
* Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff
Note: (\*) May be self-reported by subject
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03610269
Study Brief:
Protocol Section:
NCT03610269