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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT05859568
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide Informed Consent/Assent
* Adults (age +18 years) and children (8-17 years) can be enrolled in this study
* If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
* Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
* English language proficiency as determined by the investigator
Exclusion Criteria:
• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT05859568
Study Brief:
Protocol Section:
NCT05859568