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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT02262195
Eligibility Criteria:
Inclusion Criteria:
* Subjects does not have significant medical problems
* Subject is willing to provide written informed consent
* Subject is between 18 and 45 years of age
Exclusion Criteria:
* Has a BMI greater than 31
* Has had any relevant injury at the sensor location site
* Has deformities or abnormalities that may prevent proper application of the device under test
* Has a known respiratory condition
* Is currently a smoker
* Has a known heart or cardiovascular condition
* Is currently pregnant
* Is female and actively trying to get pregnant
* Has a clotting disorder
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)
* The subject has a COHb greater than 3% or MetHb greater than 2%
* Has taken blood thinners or medication with aspirin within the last 24 hours
* Has unacceptable collateral circulation from the ulnar artery
* Has donated more than 300 mL of blood within one month prior to start of study
* Is unwilling or unable to provide written informed consent to participate in the study
* Is unwilling or unable to comply with the study procedures
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02262195
Study Brief:
Protocol Section:
NCT02262195