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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT04573595
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
* Subject must be willing and able to comply with the study procedures.
* Subjects must be ≥ 13 years of age for Phase 1.
* Subjects must be ≥ 3 years of age for Phase 2 and 3.
* Subjects that are between 7 and 17 years of age must provide Assent to participate in the study.
* Subject or legally authorized representative must be able to read or write in English.
* Subjects must have an arm circumference in the range of 13-55cm or a thigh circumference in the range of 50-70 cm circumference.
* At least 30% of subjects shall be male and at least 30% of subjects shall be female.
Exclusion Criteria:
* Lack of Informed Consent
* Subjects with deformities or abnormalities that may prevent proper application of the Device Under Test.
* Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
* Subjects with known heart dysrhythmias.
* Subjects with compromised circulation or peripheral vascular disease.
* Subjects with clotting disorders or taking blood thinners.
* Subjects that cannot tolerate sitting for up to 1 hour.
* Subject with a blood pressure demographic that has already been filled.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT04573595
Study Brief:
Protocol Section:
NCT04573595