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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT02930850
Eligibility Criteria:
Inclusion Criteria:
* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
Exclusion Criteria:
* 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 burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* 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.
* Decision-impaired adult and pediatric subjects who are unable to give consent and assent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT02930850
Study Brief:
Protocol Section:
NCT02930850