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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT06633861
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects (aged 18 years or older) willing and able to understand and provide written informed consent
* Paediatric subjects aged 16 years and older willing and able to understand and provide written informed consent
* Paediatric subjects aged approx. 4-16 years and their legal guardians, willing and able to understand and provide written informed consent/assent
* Subject weight within intended use of at least one SpO2 sensor under test at time of enrolment (M1191T: adult patients \>50kg, M1196T: adult patients \>40kg, M1192A: paediatric patients 15-50kg)
* Willing and able to wear study devices during study procedures
* Subject undergoing regular spot-check measurements as per the site's standard of care
Exclusion Criteria:
* Palliative patients
* Critically ill patients with severe physiological instability (NEWS ≥9)
* Injury/wounds or physical malformation of sensor application site (i.e. fingers, toes, hands, feet)
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
* Unwillingness or inability to remove coloured nail polish or artificial nails from application site
* Nail fungus on application site
* Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT06633861
Study Brief:
Protocol Section:
NCT06633861