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:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT03030833
Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 50 years of age (self-reported).
* The subject does not have significant medical problems (self-reported).
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
* Exclusion Criteria:
* Has a BMI greater than 30.0 (calculated from self-reported weight and height).
* Has had any relevant injury at the sensor location site (self-reported).
* Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
* Has a known respiratory condition (self-reported).
* Is currently a smoker (self-reported).
* Has a known heart or cardiovascular condition (self-reported).
* Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
* Is female and actively trying to get pregnant (self-reported).
* Has a clotting disorder (self-reported).
* Has Raynaud's Disease (self-reported).
* Is known to have anemia (hemoglobin value below lower range of normal for gender)
* Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
* Is known to have a inherited or congenital methemoglobinemia (self-reported).
* Has unacceptable collateral circulation from the ulnar artery (based on exam).
* Is unwilling or unable to provide written informed consent to participate in the study.
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03030833
Study Brief:
Protocol Section:
NCT03030833